This example shows a combined dataset from multiple studies: the examples from Sections 6, Example: One Subject, Single Dose, and 7, Example: One Subject, Multiple Doses, are combined with the addition of an IV dose. This combined example includes both a tablet and IV.
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PROJID | PROJIDN | STUDYID | STUDYIDN | PART | EXTEN | USUBJID | USUBJIDN | SUBJID | SITEID | SITEIDN | AVISIT | AVISITN | VISIT | VISITNUM | AFRLT | TPTREF | APRLT | NFRLT | NPRLT | ATPT | ATPTN | ADT | ATM | ADY | AENDT | AENTM | OCC | DVID | DVIDN | CMT | DV | DVL | EVID | MDV | AULOQ | ALLOQ | BLQFN | BLQFL | ALQFN | ALQFL | DOSEA | DOSEP | AMT | II | ADDL | SS | RATE | DUR | FORM | FORMN | ROUTE | ROUTEN | TRTP | TRTPN | TRTA | TRTAN | APHASE | APHASEN | APERIOD | APERIODC | ARM | ARMN | ACTARM | ACTARMN | COHORT | COHORTN | WT | WTBL | HTBL | BMIBL | BSABL | AGE | SEX | SEXN | RACE | RACEN | ETHNIC | ETHNICN | REGION | REGIONN | COUNTRY | COUNTRYN | CREATBL | UCREATBL | CRCLBL | EGFRBL | TBILBL | ASTBL | ALTBL | AVAL | PCSTRESC | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | -0.1 | DAY 1 DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-05-21 | 07:54 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | . | BLQ | ||
2 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | -0.1 | DAY 1 DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-05-21 | 07:54 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 87.03 | 4.466299 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 87.03 | 87.03 | ||
3 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0 | DAY 1 DOSE | 0 | 0 | 0 | DOSE | 0 | 2020-05-21 | 08:00 | 1 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | . | |||
4 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.25 | DAY 1 DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-05-21 | 08:15 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 1.97 | 0.678629 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 1.97 | 1.97 | ||
5 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.25 | DAY 1 DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-05-21 | 08:15 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 70.02 | 4.248754 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 70.02 | 70.02 | ||
6 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.5 | DAY 1 DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-05-21 | 08:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 2.98 | 1.090316 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.98 | 2.98 | ||
7 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.5 | DAY 1 DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-05-21 | 08:30 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 73.69 | 4.299825 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 73.69 | 73.69 | ||
8 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.75 | DAY 1 DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-05-21 | 08:45 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 6.44 | 1.861801 | 0 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 6.44 | 6.44 | ||
9 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.75 | DAY 1 DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-05-21 | 08:45 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 76.98 | 4.343546 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 76.98 | 76.98 | ||
10 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1 | DAY 1 DOSE | 1 | 1 | 1 | 1H | 1 | 2020-05-21 | 09:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 9.80 | 2.282835 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.80 | 9.8 | ||
11 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1 | DAY 1 DOSE | 1 | 1 | 1 | 1H | 1 | 2020-05-21 | 09:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 65.98 | 4.189386 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 65.98 | 65.98 | ||
12 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1.5 | DAY 1 DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-05-21 | 09:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.41 | 2.518406 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 12.41 | 12.41 | ||
13 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1.5 | DAY 1 DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-05-21 | 09:30 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 71.67 | 4.272099 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 71.67 | 71.67 | ||
14 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 2 | DAY 1 DOSE | 2 | 2 | 2 | 2H | 2 | 2020-05-21 | 10:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 9.21 | 2.219783 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.21 | 9.21 | ||
15 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 2 | DAY 1 DOSE | 2 | 2 | 2 | 2H | 2 | 2020-05-21 | 10:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 81.56 | 4.401337 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 81.56 | 81.56 | ||
16 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 3 | DAY 1 DOSE | 3 | 3 | 3 | 3H | 3 | 2020-05-21 | 11:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 17.40 | 2.856257 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.40 | 17.4 | ||
17 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 3 | DAY 1 DOSE | 3 | 3 | 3 | 3H | 3 | 2020-05-21 | 11:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 71.20 | 4.265473 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 71.20 | 71.2 | ||
18 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 4 | DAY 1 DOSE | 4 | 4 | 4 | 4H | 4 | 2020-05-21 | 12:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 14.24 | 2.655828 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 14.24 | 14.24 | ||
19 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 4 | DAY 1 DOSE | 4 | 4 | 4 | 4H | 4 | 2020-05-21 | 12:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 60.43 | 4.101539 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 60.43 | 60.43 | ||
20 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 6 | DAY 1 DOSE | 6 | 6 | 6 | 6H | 6 | 2020-05-21 | 14:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 16.98 | 2.831832 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 16.98 | 16.98 | ||
21 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 6 | DAY 1 DOSE | 6 | 6 | 6 | 6H | 6 | 2020-05-21 | 14:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 84.68 | 4.438878 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 84.68 | 84.68 | ||
22 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 8 | DAY 1 DOSE | 8 | 8 | 8 | 8H | 8 | 2020-05-21 | 16:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.99 | 2.564352 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 12.99 | 12.99 | ||
23 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 8 | DAY 1 DOSE | 8 | 8 | 8 | 8H | 8 | 2020-05-21 | 16:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 86.48 | 4.459932 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 86.48 | 86.48 | ||
24 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 12 | DAY 1 DOSE | 12 | 12 | 12 | 12H | 12 | 2020-05-21 | 20:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 19.51 | 2.970776 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 19.51 | 19.51 | ||
25 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 12 | DAY 1 DOSE | 12 | 12 | 12 | 12H | 12 | 2020-05-21 | 20:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 75.16 | 4.319583 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 75.16 | 75.16 | ||
26 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 2 | 1 | DAY 2 | 2 | 24 | DAY 1 DOSE | 24 | 24 | 24 | 1D | 24 | 2020-05-21 | 08:00 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 12.01 | 2.485983 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 12.01 | 12.01 | ||
27 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 2 | 1 | DAY 2 | 2 | 24 | DAY 1 DOSE | 24 | 24 | 24 | 1D | 24 | 2020-05-21 | 08:00 | 2 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 89.63 | 4.495745 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 89.63 | 89.63 | ||
28 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 3 | 1 | DAY 3 | 3 | 48 | DAY 1 DOSE | 48 | 48 | 48 | 2D | 48 | 2020-05-21 | 08:00 | 3 | 1 | DRUG (ng/mL) | 1 | 2 | 10.18 | 2.320054 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 10.18 | 10.18 | ||
29 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 3 | 1 | DAY 3 | 3 | 48 | DAY 1 DOSE | 48 | 48 | 48 | 2D | 48 | 2020-05-21 | 08:00 | 3 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 80.25 | 4.385157 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 80.25 | 80.25 | ||
30 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 4 | 1 | DAY 4 | 4 | 72 | DAY 1 DOSE | 72 | 72 | 72 | 3D | 72 | 2020-05-21 | 08:00 | 4 | 1 | DRUG (ng/mL) | 1 | 2 | 8.90 | 2.185528 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.90 | 8.9 | ||
31 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 4 | 1 | DAY 4 | 4 | 72 | DAY 1 DOSE | 72 | 72 | 72 | 3D | 72 | 2020-05-21 | 08:00 | 4 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 78.60 | 4.364427 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 78.60 | 78.6 | ||
32 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 5 | 1 | DAY 5 | 5 | 96 | DAY 1 DOSE | 96 | 96 | 96 | 4D | 96 | 2020-05-21 | 08:00 | 5 | 1 | DRUG (ng/mL) | 1 | 2 | 8.31 | 2.117239 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.31 | 8.31 | ||
33 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 5 | 1 | DAY 5 | 5 | 96 | DAY 1 DOSE | 96 | 96 | 96 | 4D | 96 | 2020-05-21 | 08:00 | 5 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 70.41 | 4.254365 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 70.41 | 70.41 | ||
34 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 6 | 1 | DAY 6 | 6 | 120 | DAY 1 DOSE | 120 | 120 | 120 | 5D | 120 | 2020-05-21 | 08:00 | 6 | 1 | DRUG (ng/mL) | 1 | 2 | 6.98 | 1.943693 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 6.98 | 6.98 | ||
35 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 6 | 1 | DAY 6 | 6 | 120 | DAY 1 DOSE | 120 | 120 | 120 | 5D | 120 | 2020-05-21 | 08:00 | 6 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 75.25 | 4.320808 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 75.25 | 75.25 | ||
36 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 7 | 1 | DAY 7 | 7 | 144 | DAY 1 DOSE | 144 | 144 | 144 | 6D | 144 | 2020-05-21 | 08:00 | 7 | 1 | DRUG (ng/mL) | 1 | 2 | 2.25 | 0.810999 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.25 | 2.25 | ||
37 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 7 | 1 | DAY 7 | 7 | 144 | DAY 1 DOSE | 144 | 144 | 144 | 6D | 144 | 2020-05-21 | 08:00 | 7 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 77.43 | 4.349329 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 77.43 | 77.43 | ||
38 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 8 | 1 | DAY 8 | 8 | 168 | DAY 1 DOSE | 168 | 168 | 168 | 7D | 168 | 2020-05-21 | 08:00 | 8 | 1 | DRUG (ng/mL) | 1 | 2 | 2.50 | 0.91774 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.50 | 2.5 | ||
39 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 8 | 1 | DAY 8 | 8 | 168 | DAY 1 DOSE | 168 | 168 | 168 | 7D | 168 | 2020-05-21 | 08:00 | 8 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 85.56 | 4.449228 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 85.56 | 85.56 | ||
40 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 9 | 1 | DAY 9 | 9 | 192 | DAY 1 DOSE | 192 | 192 | 192 | 8D | 192 | 2020-05-21 | 08:00 | 9 | 1 | DRUG (ng/mL) | 1 | 2 | 2.94 | 1.078083 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.94 | 2.94 | ||
41 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 9 | 1 | DAY 9 | 9 | 192 | DAY 1 DOSE | 192 | 192 | 192 | 8D | 192 | 2020-05-21 | 08:00 | 9 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 79.61 | 4.377099 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 79.61 | 79.61 | ||
42 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 10 | 1 | DAY 10 | 10 | 216 | DAY 1 DOSE | 216 | 216 | 216 | 9D | 216 | 2020-05-21 | 08:00 | 10 | 1 | DRUG (ng/mL) | 1 | 2 | 3.19 | 1.161523 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 3.19 | 3.19 | ||
43 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 10 | 1 | DAY 10 | 10 | 216 | DAY 1 DOSE | 216 | 216 | 216 | 9D | 216 | 2020-05-21 | 08:00 | 10 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 61.60 | 4.120669 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 61.60 | 61.6 | ||
44 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 11 | 1 | DAY 11 | 11 | 240 | DAY 1 DOSE | 240 | 240 | 240 | 10D | 240 | 2020-05-21 | 08:00 | 11 | 1 | DRUG (ng/mL) | 1 | 2 | 1.04 | 0.043502 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 1.04 | 1.04 | ||
45 | PROJECT-001 | 1 | PROTOCOL-001 | 1 | 1 | 0 | PROTOCOL-001-001-00137 | 100100137 | 00137 | 001 | 1 | DAY 11 | 1 | DAY 11 | 11 | 240 | DAY 1 DOSE | 240 | 240 | 240 | 10D | 240 | 2020-05-21 | 08:00 | 11 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 73.21 | 4.293272 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg Single Dose | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 73.21 | 73.21 | ||
46 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | -0.1 | DAY 1 MORNING DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-01-21 | 07:54 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | . | BLQ | ||
47 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | -0.1 | DAY 1 MORNING DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-01-21 | 07:54 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 128.37 | 4.854907 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 128.37 | 128.37 | ||
48 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0 | DAY 1 MORNING DOSE | 0 | 0 | 0 | DOSE | 0 | 2020-01-21 | 08:00 | 1 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | 1 | 1 | N | 50 | 50 | 50 | 12 | 7 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||||||||
49 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.25 | DAY 1 MORNING DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-01-21 | 08:15 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 2.91 | 1.067237 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.91 | 2.91 | ||
50 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.25 | DAY 1 MORNING DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-01-21 | 08:15 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 103.27 | 4.637362 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 103.27 | 103.27 | ||
51 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.5 | DAY 1 MORNING DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-01-21 | 08:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 4.39 | 1.478924 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.39 | 4.39 | ||
52 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.5 | DAY 1 MORNING DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-01-21 | 08:30 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 108.68 | 4.688433 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 108.68 | 108.68 | ||
53 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.75 | DAY 1 MORNING DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-01-21 | 08:45 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 9.49 | 2.250409 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.49 | 9.49 | ||
54 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 0.75 | DAY 1 MORNING DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-01-21 | 08:45 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 113.54 | 4.732154 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 113.54 | 113.54 | ||
55 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1 | DAY 1 MORNING DOSE | 1 | 1 | 1 | 1H | 1 | 2020-01-21 | 09:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 14.46 | 2.671443 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 14.46 | 14.46 | ||
56 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1 | DAY 1 MORNING DOSE | 1 | 1 | 1 | 1H | 1 | 2020-01-21 | 09:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 97.32 | 4.577994 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 97.32 | 97.32 | ||
57 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1.5 | DAY 1 MORNING DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-01-21 | 09:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 18.30 | 2.907014 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 18.30 | 18.3 | ||
58 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 1.5 | DAY 1 MORNING DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-01-21 | 09:30 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 105.71 | 4.660707 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 105.71 | 105.71 | ||
59 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 2 | DAY 1 MORNING DOSE | 2 | 2 | 2 | 2H | 2 | 2020-01-21 | 10:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 13.58 | 2.608391 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 13.58 | 13.58 | ||
60 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 2 | DAY 1 MORNING DOSE | 2 | 2 | 2 | 2H | 2 | 2020-01-21 | 10:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 120.29 | 4.789945 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 120.29 | 120.29 | ||
61 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 3 | DAY 1 MORNING DOSE | 3 | 3 | 3 | 3H | 3 | 2020-01-21 | 11:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 25.66 | 3.244865 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 25.66 | 25.66 | ||
62 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 3 | DAY 1 MORNING DOSE | 3 | 3 | 3 | 3H | 3 | 2020-01-21 | 11:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 105.01 | 4.654081 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 105.01 | 105.01 | ||
63 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 4 | DAY 1 MORNING DOSE | 4 | 4 | 4 | 4H | 4 | 2020-01-21 | 12:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 21.00 | 3.044436 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 21.00 | 21 | ||
64 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 4 | DAY 1 MORNING DOSE | 4 | 4 | 4 | 4H | 4 | 2020-01-21 | 12:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 89.13 | 4.490147 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 89.13 | 89.13 | ||
65 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 6 | DAY 1 MORNING DOSE | 6 | 6 | 6 | 6H | 6 | 2020-01-21 | 14:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 25.04 | 3.22044 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 25.04 | 25.04 | ||
66 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 6 | DAY 1 MORNING DOSE | 6 | 6 | 6 | 6H | 6 | 2020-01-21 | 14:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 124.90 | 4.827486 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 124.90 | 124.9 | ||
67 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 8 | DAY 1 MORNING DOSE | 8 | 8 | 8 | 8H | 8 | 2020-01-21 | 16:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 19.16 | 2.95296 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 19.16 | 19.16 | ||
68 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 8 | DAY 1 MORNING DOSE | 8 | 8 | 8 | 8H | 8 | 2020-01-21 | 16:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 127.55 | 4.84854 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 127.55 | 127.55 | ||
69 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 12 | DAY 1 MORNING DOSE | 12 | 12 | 12 | 12H | 12 | 2020-01-21 | 20:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 28.77 | 3.359384 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 28.77 | 28.77 | ||
70 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 1 | 1 | DAY 1 | 1 | 12 | DAY 1 MORNING DOSE | 12 | 12 | 12 | 12H | 12 | 2020-01-21 | 20:00 | 1 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 110.85 | 4.708191 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 110.85 | 110.85 | ||
71 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 2 | 2 | DAY 2 | 2 | 24 | DAY 1 AFTERNOON DOSE | 12 | 24 | 12 | PREDOSE | 0 | 2020-01-22 | 08:00 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 17.72 | 2.874591 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.72 | 17.72 | ||
72 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 2 | 2 | DAY 2 | 2 | 24 | DAY 1 AFTERNOON DOSE | 12 | 24 | 12 | PREDOSE | 0 | 2020-01-22 | 08:00 | 2 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 132.20 | 4.884353 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 132.20 | 132.2 | ||
73 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 3 | 3 | DAY 3 | 3 | 48 | DAY 2 AFTERNOON DOSE | 12 | 48 | 12 | PREDOSE | 0 | 2020-01-23 | 08:00 | 3 | 1 | DRUG (ng/mL) | 1 | 2 | 17.01 | 2.833753 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.01 | 17.01 | ||
74 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 3 | 3 | DAY 3 | 3 | 48 | DAY 2 AFTERNOON DOSE | 12 | 48 | 12 | PREDOSE | 0 | 2020-01-23 | 08:00 | 3 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 118.36 | 4.773765 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 118.36 | 118.36 | ||
75 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 4 | 4 | DAY 4 | 4 | 72 | DAY 3 AFTERNOON DOSE | 12 | 72 | 12 | PREDOSE | 0 | 2020-01-24 | 08:00 | 4 | 1 | DRUG (ng/mL) | 1 | 2 | 17.32 | 2.851861 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.32 | 17.32 | ||
76 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 4 | 4 | DAY 4 | 4 | 72 | DAY 3 AFTERNOON DOSE | 12 | 72 | 12 | PREDOSE | 0 | 2020-01-24 | 08:00 | 4 | 1 | BIOMARKER (ng/mL) | 2 | 5 | 115.94 | 4.753035 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 115.94 | 115.94 | ||
77 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 95.9 | DAY 4 AFTERNOON DOSE | 11.06 | 96 | 12 | PREDOSE | 0 | 2020-01-25 | 07:54 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 17.32 | 2.851861 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.32 | 17.32 | ||
78 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 95.9 | DAY 4 AFTERNOON DOSE | 11.06 | 96 | 12 | PREDOSE | 0 | 2020-01-25 | 07:54 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 128.37 | 4.854907 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 128.37 | 128.37 | ||
79 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 95.9 | DAY 5 MORNING DOSE | 0 | 95.9 | 0 | DOSE | 0 | 2020-01-25 | 0.333333 | 5 | 2 | TEST PRODUCT (mg) | 0 | 1 | . | 1 | 1 | 50 | 50 | 50 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | |||||||||||
80 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.25 | DAY 5 MORNING DOSE | 0.25 | 96.25 | 0.25 | 15MIN | 0.25 | 2020-01-25 | 08:15 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 19.91 | 2.991088 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 19.91 | 19.91 | ||
81 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.25 | DAY 5 MORNING DOSE | 0.25 | 96.25 | 0.25 | 15MIN | 0.25 | 2020-01-25 | 08:15 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 103.27 | 4.637362 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 103.27 | 103.27 | ||
82 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.5 | DAY 5 MORNING DOSE | 0.5 | 96.5 | 0.5 | 30MIN | 0.5 | 2020-01-25 | 08:30 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 21.39 | 3.06284 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 21.39 | 21.39 | ||
83 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.5 | DAY 5 MORNING DOSE | 0.5 | 96.5 | 0.5 | 30MIN | 0.5 | 2020-01-25 | 08:30 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 108.68 | 4.688433 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 108.68 | 108.68 | ||
84 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.75 | DAY 5 MORNING DOSE | 0.75 | 96.75 | 0.75 | 45MIN | 0.75 | 2020-01-25 | 08:45 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 26.49 | 3.276828 | 0 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 26.49 | 26.49 | ||
85 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 96.75 | DAY 5 MORNING DOSE | 0.75 | 96.75 | 0.75 | 45MIN | 0.75 | 2020-01-25 | 08:45 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 113.54 | 4.732154 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 113.54 | 113.54 | ||
86 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 97 | DAY 5 MORNING DOSE | 1 | 97 | 1 | 1H | 1 | 2020-01-25 | 09:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 31.46 | 3.448743 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 31.46 | 31.46 | ||
87 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 97 | DAY 5 MORNING DOSE | 1 | 97 | 1 | 1H | 1 | 2020-01-25 | 09:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 97.32 | 4.577994 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 97.32 | 97.32 | ||
88 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 97.5 | DAY 5 MORNING DOSE | 1.5 | 97.5 | 1.5 | 1H30MIN | 1.5 | 2020-01-25 | 09:30 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 35.30 | 3.563942 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 35.30 | 35.3 | ||
89 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 97.5 | DAY 5 MORNING DOSE | 1.5 | 97.5 | 1.5 | 1H30MIN | 1.5 | 2020-01-25 | 09:30 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 105.71 | 4.660707 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 105.71 | 105.71 | ||
90 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 98 | DAY 5 MORNING DOSE | 2 | 98 | 2 | 2H | 2 | 2020-01-25 | 10:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 30.58 | 3.420254 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 30.58 | 30.58 | ||
91 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 98 | DAY 5 MORNING DOSE | 2 | 98 | 2 | 2H | 2 | 2020-01-25 | 10:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 2120.29 | 4.789945 | 0 | 0 | 2000 | 10 | 1 | Y | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2120.29 | 2120.29 | ||
92 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 99 | DAY 5 MORNING DOSE | 3 | 99 | 3 | 3H | 3 | 2020-01-25 | 11:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 42.66 | 3.753221 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 42.66 | 42.66 | ||
93 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 99 | DAY 5 MORNING DOSE | 3 | 99 | 3 | 3H | 3 | 2020-01-25 | 11:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 105.01 | 4.654081 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 105.01 | 105.01 | ||
94 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 100 | DAY 5 MORNING DOSE | 4 | 100 | 4 | 4H | 4 | 2020-01-25 | 12:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 38.00 | 3.637538 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 38.00 | 38 | ||
95 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 100 | DAY 5 MORNING DOSE | 4 | 100 | 4 | 4H | 4 | 2020-01-25 | 12:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 89.13 | 4.490147 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 89.13 | 89.13 | ||
96 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 102 | DAY 5 MORNING DOSE | 6 | 102 | 6 | 6H | 6 | 2020-01-25 | 14:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 42.04 | 3.738601 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 42.04 | 42.04 | ||
97 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 102 | DAY 5 MORNING DOSE | 6 | 102 | 6 | 6H | 6 | 2020-01-25 | 14:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 124.90 | 4.827486 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 124.90 | 124.9 | ||
98 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 104 | DAY 5 MORNING DOSE | 8 | 104 | 8 | 8H | 8 | 2020-01-25 | 16:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 36.16 | 3.588025 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 36.16 | 36.16 | ||
99 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 104 | DAY 5 MORNING DOSE | 8 | 104 | 8 | 8H | 8 | 2020-01-25 | 16:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 127.55 | 4.84854 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 127.55 | 127.55 | ||
100 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 108 | DAY 5 MORNING DOSE | 12 | 108 | 12 | 12H | 12 | 2020-01-25 | 20:00 | 5 | 2 | DRUG (ng/mL) | 1 | 2 | 45.77 | 3.823661 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 45.77 | 45.77 | ||
101 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 5 | 5 | DAY 5 | 5 | 108 | DAY 5 MORNING DOSE | 12 | 108 | 12 | 12H | 12 | 2020-01-25 | 20:00 | 5 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 110.85 | 4.708191 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 110.85 | 110.85 | ||
102 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 6 | 6 | DAY 6 | 6 | 120 | DAY 5 MORNING DOSE | 24 | 120 | 24 | 24H | 24 | 2020-01-26 | 08:00 | 6 | 2 | DRUG (ng/mL) | 1 | 2 | 17.30 | 2.8508 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 17.30 | 17.3 | ||
103 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 6 | 6 | DAY 6 | 6 | 120 | DAY 5 MORNING DOSE | 24 | 120 | 24 | 24H | 24 | 2020-01-26 | 08:00 | 6 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 110.99 | 4.709416 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 110.99 | 110.99 | ||
104 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 7 | 7 | DAY 7 | 7 | 144 | DAY 5 MORNING DOSE | 48 | 144 | 48 | 2D | 48 | 2020-01-27 | 08:00 | 7 | 2 | DRUG (ng/mL) | 1 | 2 | 3.32 | 1.199607 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 3.32 | 3.32 | ||
105 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 7 | 7 | DAY 7 | 7 | 144 | DAY 5 MORNING DOSE | 48 | 144 | 48 | 2D | 48 | 2020-01-27 | 08:00 | 7 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 114.20 | 4.737937 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 114.20 | 114.2 | ||
106 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 8 | 8 | DAY 8 | 8 | 168 | DAY 5 MORNING DOSE | 72 | 168 | 72 | 3D | 72 | 2020-01-28 | 08:00 | 8 | 2 | DRUG (ng/mL) | 1 | 2 | 3.69 | 1.306348 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 3.69 | 3.69 | ||
107 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 8 | 8 | DAY 8 | 8 | 168 | DAY 5 MORNING DOSE | 72 | 168 | 72 | 3D | 72 | 2020-01-28 | 08:00 | 8 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 126.20 | 4.837836 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 126.20 | 126.2 | ||
108 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 9 | 9 | DAY 9 | 9 | 192 | DAY 5 MORNING DOSE | 96 | 192 | 96 | 4D | 96 | 2020-01-29 | 08:00 | 9 | 2 | DRUG (ng/mL) | 1 | 2 | 4.33 | 1.466691 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.33 | 4.33 | ||
109 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 9 | 9 | DAY 9 | 9 | 192 | DAY 5 MORNING DOSE | 96 | 192 | 96 | 4D | 96 | 2020-01-29 | 08:00 | 9 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 117.41 | 4.765707 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 117.41 | 117.41 | ||
110 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 10 | 10 | DAY 10 | 10 | 216 | DAY 5 MORNING DOSE | 120 | 216 | 120 | 5D | 120 | 2020-01-30 | 08:00 | 10 | 2 | DRUG (ng/mL) | 1 | 2 | 4.71 | 1.550131 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.71 | 4.71 | ||
111 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 10 | 10 | DAY 10 | 10 | 216 | DAY 5 MORNING DOSE | 120 | 216 | 120 | 5D | 120 | 2020-01-30 | 08:00 | 10 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 90.86 | 4.509277 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 90.86 | 90.86 | ||
112 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 11 | 11 | DAY 11 | 11 | 240 | DAY 5 MORNING DOSE | 144 | 240 | 144 | 6D | 144 | 2020-01-31 | 08:00 | 11 | 2 | DRUG (ng/mL) | 1 | 2 | 0.00 | 0.43211 | 0 | 0 | 10000 | 1 | 1 | Y | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 0.00 | BLQ | ||
113 | PROJECT-001 | 1 | PROTOCOL-002 | 2 | 1 | 0 | PROTOCOL-002-001-00237 | 200100237 | 00237 | 001 | 1 | DAY 11 | 11 | DAY 11 | 11 | 240 | DAY 5 MORNING DOSE | 144 | 240 | 144 | 6D | 144 | 2020-01-31 | 08:00 | 11 | 2 | BIOMARKER (ng/mL) | 2 | 5 | 107.97 | 4.68188 | 0 | 0 | 2000 | 10 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | DOSE ESCALATION | 1 | 1 | BEFORE CROSSOVER | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | TEST DRUG 100 mg BID | 1 | 70 | 70 | 170 | 24.2 | 1.81 | 30 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 107.97 | 107.97 | ||
114 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | -0.1 | CYCLE 1 DAY 1 DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2020-09-21 | 07:54 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | LLOQ <= 1 | |||
115 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 0 | CYCLE 1 DAY 1 DOSE | 0 | 0 | 0 | DOSE | 0 | 2020-09-21 | 08:00 | 1 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 50 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
116 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 0.25 | CYCLE 1 DAY 1 DOSE | 0.25 | 0.25 | 0.25 | 15MIN | 0.25 | 2020-09-21 | 08:15 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 1.28 | 0.799881 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 1.28 | 1.28 | ||
117 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 0.5 | CYCLE 1 DAY 1 DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2020-09-21 | 08:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 1.93 | 1.211567 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 1.93 | 1.93 | ||
118 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 0.75 | CYCLE 1 DAY 1 DOSE | 0.75 | 0.75 | 0.75 | 45MIN | 0.75 | 2020-09-21 | 08:45 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 4.17 | 1.983053 | 0 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.17 | 4.17 | ||
119 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 1 | CYCLE 1 DAY 1 DOSE | 1 | 1 | 1 | 1H | 1 | 2020-09-21 | 09:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 6.37 | 2.404086 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 6.37 | 6.37 | ||
120 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 1.5 | CYCLE 1 DAY 1 DOSE | 1.5 | 1.5 | 1.5 | 1H30MIN | 1.5 | 2020-09-21 | 09:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 8.06 | 2.639658 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.06 | 8.06 | ||
121 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 2 | CYCLE 1 DAY 1 DOSE | 2 | 2 | 2 | 2H | 2 | 2020-09-21 | 10:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 5.97 | 2.341034 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 5.97 | 5.97 | ||
122 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 3 | CYCLE 1 DAY 1 DOSE | 3 | 3 | 3 | 3H | 3 | 2020-09-21 | 11:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 11.29 | 2.977508 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 11.29 | 11.29 | ||
123 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 4 | CYCLE 1 DAY 1 DOSE | 4 | 4 | 4 | 4H | 4 | 2020-09-21 | 12:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 9.24 | 2.777079 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.24 | 9.24 | ||
124 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 6 | CYCLE 1 DAY 1 DOSE | 6 | 6 | 6 | 6H | 6 | 2020-09-21 | 14:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 11.02 | 2.953083 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 11.02 | 11.02 | ||
125 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 8 | CYCLE 1 DAY 1 DOSE | 8 | 8 | 8 | 8H | 8 | 2020-09-21 | 16:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 8.44 | 2.685603 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.44 | 8.44 | ||
126 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 1 | 1 | 12 | CYCLE 1 DAY 1 DOSE | 12 | 12 | 12 | 12H | 12 | 2020-09-21 | 20:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.66 | 3.092027 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 12.66 | 12.66 | ||
127 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 1 | 1 | CYCLE 1 DAY 2 | 2 | 23.917 | CYCLE 1 DAY 1 DOSE | 23.917 | 24 | 24 | 1D | 24 | 2020-09-22 | 07:55 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 7.80 | 2.607234 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 7.80 | 7.8 | ||
128 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 2 | 1 | CYCLE 1 DAY 2 | 1 | 0 | CYCLE 1 DAY 2 DOSE | 0 | 24 | 0 | DOSE | 0 | 2020-09-22 | 08:00 | 2 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 50 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | |||||
129 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 2 | 1 | CYCLE 1 DAY 1 | 1 | 24.45 | CYCLE 1 DAY 2 DOSE | 0.45 | 24.5 | 0.5 | 30MIN | 0.5 | 2020-09-22 | 08:27 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 2.28 | 0.824175 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 2.28 | 2.28 | ||
130 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 2 | 1 | CYCLE 1 DAY 1 | 1 | 26 | CYCLE 1 DAY 2 DOSE | 2 | 26 | 2 | 2H | 2 | 2020-09-22 | 10:00 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 7.05 | 1.953028 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 7.05 | 7.05 | ||
131 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 2 | 1 | CYCLE 1 DAY 1 | 1 | 32 | CYCLE 1 DAY 2 DOSE | 8 | 32 | 8 | 8H | 8 | 2020-09-22 | 16:00 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 9.95 | 2.297573 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 9.95 | 9.95 | ||
132 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 1 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 1 DAY 3 | 1 | CYCLE 1 DAY 3 | 1 | 48.17 | CYCLE 1 DAY 3 DOSE | 0 | 48 | 0 | DOSE | 0 | 2020-09-23 | 08:10 | 3 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 50 | 50 | 50 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 50 mg | 1 | TEST DRUG 50 mg | 1 | CYCLE 1 | 1 | 1 | CYCLE 1 | TEST DRUG 50 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 50 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
133 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 1 | 1 | CYCLE 2 DAY 1 | 1 | 264 | CYCLE 2 DAY 1 DOSE | 0 | 264 | 0 | DOSE | 0 | 2020-10-02 | 08:00 | 12 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 75 | 75 | 75 | 24 | 5 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 75 mg | 1 | TEST DRUG 75 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 75 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 75 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
134 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 7 | 1 | CYCLE 2 DAY 7 | 1 | 408 | CYCLE 2 DAY 7 DOSE | 0 | 408 | 0 | DOSE | 0 | 2020-10-08 | 08:00 | 18 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 24 | 9 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
135 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 17 | 1 | CYCLE 2 DAY 17 | 1 | 648 | CYCLE 2 DAY 17 DOSE | 0 | 648 | 0 | DOSE | 0 | 2020-10-18 | 08:00 | 28 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | ||||
136 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 671.83 | CYCLE 2 DAY 17 DOSE | -0.1 | 672 | 0 | PREDOSE | 0 | 2020-10-19 | 07:50 | 29 | 1 | DRUG (ng/mL) | 1 | 2 | 4.95 | 1.599388 | 0 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 4.95 | 4.95 | ||
137 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 672 | CYCLE 2 DAY 18 DOSE | 0 | 672 | 0 | DOSE | 0 | 2020-10-19 | 08:00 | 29 | 1 | TEST PRODUCT (mg) | 0 | 1 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | . | . | ||
138 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 672.5 | CYCLE 2 DAY 18 DOSE | 0.5 | 672.5 | 0.5 | 30MIN | 0.5 | 2020-10-19 | 08:30 | 29 | 1 | DRUG (ng/mL) | 1 | 2 | 8.03 | 2.083185 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 8.03 | 8.03 | ||
139 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 674 | CYCLE 2 DAY 18 DOSE | 2 | 674 | 2 | 2H | 2 | 2020-10-19 | 10:00 | 29 | 1 | DRUG (ng/mL) | 1 | 2 | 24.83 | 3.212053 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 24.83 | 24.83 | ||
140 | PROJECT-001 | 1 | PROTOCOL-005 | 3 | 2 | 0 | PROTOCOL-005-003-00485 | 500300485 | 00485 | 003 | 3 | CYCLE 2 DAY 18 | 1 | CYCLE 2 DAY 18 | 1 | 680.33 | CYCLE 2 DAY 18 DOSE | 8 | 680 | 8 | 8H | 8 | 2020-10-19 | 16:20 | 29 | 1 | DRUG (ng/mL) | 1 | 2 | 35.05 | 3.556776 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | TABLET | 1 | ORAL | 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | CYCLE 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 69 | 175 | 22.5 | 1.84 | 40 | M | 1 | WHITE | 1 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.2 | 1500 | 100 | 90 | 1 | 20 | 30 | 35.05 | 35.05 | ||
141 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | -0.1 | DAY 1 DOSE | -0.1 | 0 | 0 | PREDOSE | 0 | 2021-01-07 | 07:54 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | LLOQ <= 1 | |||
142 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 0 | DAY 1 DOSE | 0 | 0 | 0 | DOSE | 0 | 2021-01-07 | 08:00 | 1 | 2021-01-07 | 08:30 | 1 | TEST PRODUCT (mg) | 0 | 2 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | 200 | 0.5 | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | ||
143 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 0.5 | DAY 1 DOSE | 0.5 | 0.5 | 0.5 | 30MIN | 0.5 | 2021-01-07 | 08:30 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 14.76 | 2.691921 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 14.76 | 14.76 | ||
144 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 1.083 | DAY 1 DOSE | 1.083 | 1 | 1 | 1H | 1 | 2021-01-07 | 09:03 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 13.28 | 2.586259 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 13.28 | 13.28 | ||
145 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 3 | DAY 1 DOSE | 3 | 3 | 3 | 3H | 3 | 2021-01-07 | 11:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.53 | 2.528126 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 12.53 | 12.53 | ||
146 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 6 | DAY 1 DOSE | 6 | 6 | 6 | 6H | 6 | 2021-01-07 | 14:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 13.69 | 2.616666 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 13.69 | 13.69 | ||
147 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 8.167 | DAY 1 DOSE | 8.167 | 8 | 8 | 8H | 8 | 2021-01-07 | 16:06 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 12.32 | 2.511224 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 12.32 | 12.32 | ||
148 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 12 | DAY 1 DOSE | 12 | 12 | 12 | 12H | 12 | 2021-01-07 | 20:00 | 1 | 1 | DRUG (ng/mL) | 1 | 2 | 8.62 | 2.154085 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 8.62 | 8.62 | ||
149 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 24.5 | DAY 1 DOSE | 24.5 | 24 | 24 | 24H | 24 | 2021-01-08 | 08:30 | 2 | 1 | DRUG (ng/mL) | 1 | 2 | 6.34 | 1.846879 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 6.34 | 6.34 | ||
150 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 48 | DAY 1 DOSE | 48 | 48 | 48 | 48H | 48 | 2021-01-09 | 08:00 | 3 | 1 | DRUG (ng/mL) | 1 | 2 | 2.32 | 0.841567 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 2.32 | 2.32 | ||
151 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 1 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY1 | 1 | DAY1 | 1 | 72 | DAY 1 DOSE | 72 | 72 | 72 | 72H | 72 | 2021-01-10 | 08:00 | 4 | 1 | DRUG (ng/mL) | 1 | 2 | . | . | 0 | 1 | 10000 | 1 | 1 | Y | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 1 | PERIOD 1 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 69 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | LLOQ <= 1 | |||
152 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY14 | 2 | DAY14 | 2 | 336 | DAY 14 DOSE | 0 | 336 | 0 | DOSE | 0 | 2021-01-21 | 08:00 | 14 | 2021-01-21 | 08:30 | 1 | TEST PRODUCT (mg) | 0 | 2 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | 200 | 0.5 | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 72 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | ||
153 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY15 | 3 | DAY15 | 3 | 360 | DAY 15 DOSE | 0 | 360 | 0 | DOSE | 0 | 2021-01-22 | 08:00 | 15 | 2021-01-22 | 08:30 | 1 | TEST PRODUCT (mg) | 0 | 2 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 24 | 5 | 0 | 200 | 0.5 | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 72 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | ||
154 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 503.9 | DAY 20 DOSE | -0.1 | 504 | 0 | PREDOSE | 0 | 2021-01-28 | 07:54 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 9.66 | 2.267994 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 72 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 9.66 | 9.66 | ||
155 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 504 | DAY 21 DOSE | 0 | 504 | 0 | DOSE | 0 | 2021-01-28 | 08:00 | 21 | 2021-01-28 | 08:30 | 1 | TEST PRODUCT (mg) | 0 | 2 | . | . | 1 | 1 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 100 | 0 | 0 | 0 | 200 | 0.5 | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | ||
156 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 504.583 | DAY 21 DOSE | 0.583 | 504.5 | 0.5 | 30MIN | 0.5 | 2021-01-28 | 08:36 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 24.288 | 3.189982 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 24.288 | 24.288 | ||
157 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 505 | DAY 21 DOSE | 1 | 505 | 1 | 1H | 1 | 2021-01-28 | 09:00 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 22.676 | 3.121307 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 22.676 | 22.676 | ||
158 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 507 | DAY 21 DOSE | 3 | 507 | 3 | 3H | 3 | 2021-01-28 | 11:00 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 21.398 | 3.063297 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 21.398 | 21.398 | ||
159 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 510.167 | DAY 21 DOSE | 6.167 | 510 | 6 | 6H | 6 | 2021-01-28 | 14:06 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 21.765 | 3.080303 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 21.765 | 21.765 | ||
160 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 512 | DAY 21 DOSE | 8 | 512 | 8 | 8H | 8 | 2021-01-28 | 16:00 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 19.867 | 2.98906 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 19.867 | 19.867 | ||
161 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 516.167 | DAY 21 DOSE | 12.167 | 516 | 12 | 12H | 12 | 2021-01-28 | 20:06 | 21 | 1 | DRUG (ng/mL) | 1 | 2 | 28.895 | 3.363669 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 28.895 | 28.895 | ||
162 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 528 | DAY 21 DOSE | 24 | 528 | 24 | 24H | 24 | 2021-01-29 | 08:00 | 22 | 1 | DRUG (ng/mL) | 1 | 2 | 15.11 | 2.715357 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 15.11 | 15.11 | ||
163 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 552 | DAY 21 DOSE | 48 | 552 | 48 | 48H | 48 | 2021-01-30 | 08:00 | 23 | 1 | DRUG (ng/mL) | 1 | 2 | 6.34 | 1.846879 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 6.34 | 6.34 | ||
164 | PROJECT-001 | 1 | PROTOCOL-006 | 4 | 2 | 0 | PROTOCOL-006-001-00013 | 600100013 | 00013 | 001 | 1 | DAY21 | 4 | DAY21 | 4 | 578 | DAY 21 DOSE | 74 | 576 | 72 | 72H | 72 | 2021-01-31 | 10:00 | 24 | 1 | DRUG (ng/mL) | 1 | 2 | 2.32 | 0.841567 | 0 | 0 | 10000 | 1 | 0 | N | 0 | N | 100 | 100 | 0 | 0 | 0 | 0 | . | . | IV | 2 | IV | 2 | TEST DRUG 100 mg | 2 | TEST DRUG 100 mg | 1 | DOSE ESCALATION | 1 | 2 | PERIOD 2 | TEST DRUG 100 mg | 1 | TEST DRUG 100 mg Single Dose | 1 | TEST DRUG 100 mg | 1 | 71 | 70 | 175 | 22.5 | 1.84 | 48 | M | 1 | BLACK OR AFRICAN AMERICAN | 2 | Non-Hispanic | 1 | North America | 1 | UNITED STATES | 1 | 1.07 | 1400 | 84 | 82 | 1.1 | 21 | 40 | 2.32 | 2.32 |