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his example shows a combined dataset from multiple studies, with the addition of an IV dose. This combined example includes both a tablet and IV.

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PROJIDPROJIDNSTUDYIDSTUDYIDNPARTEXTENUSUBJIDUSUBJIDNSUBJIDSITEIDSITEIDNAVISITAVISITNVISITVISITNUMAFRLTTPTREFAPRLTNFRLTNPRLTATPTATPTNADTATMADYAENDTAENTMOCCDVIDDVIDNCMTDVDVLEVIDMDVAULOQALLOQBLQFNBLQFLALQFNALQFLDOSEADOSEPAMTIIADDLSSRATEDURFORMFORMNROUTEROUTENTRTPTRTPNTRTATRTANAPHASEAPHASENAPERIODAPERIODCARMARMNACTARMACTARMNCOHORTCOHORTNWTWTBLHTBLBMIBLBSABLAGESEXSEXNRACERACENETHNICETHNICNREGIONREGIONNCOUNTRYCOUNTRYNCREATBLUCREATBLCRCLBLEGFRBLTBILBLASTBLALTBLAVALPCSTRESC
1PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 11-0.1DAY 1 DOSE-0.100PREDOSE02020-05-2107:541

1DRUG (ng/mL)12..011000011Y0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030.BLQ
2PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 11-0.1DAY 1 DOSE-0.100PREDOSE02020-05-2107:541

1BIOMARKER (ng/mL)2587.034.466299002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203087.0387.03
3PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 110DAY 1 DOSE000DOSE02020-05-2108:001

1TEST PRODUCT (mg)01..111000010N0N100100100000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030.
4PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 110.25DAY 1 DOSE0.250.250.2515MIN0.252020-05-2108:151

1DRUG (ng/mL)121.970.678629001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120301.971.97
5PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 110.25DAY 1 DOSE0.250.250.2515MIN0.252020-05-2108:151

1BIOMARKER (ng/mL)2570.024.248754002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203070.0270.02
6PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 110.5DAY 1 DOSE0.50.50.530MIN0.52020-05-2108:301

1DRUG (ng/mL)122.981.090316001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120302.982.98
7PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 110.5DAY 1 DOSE0.50.50.530MIN0.52020-05-2108:301

1BIOMARKER (ng/mL)2573.694.299825002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203073.6973.69
8PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 110.75DAY 1 DOSE0.750.750.7545MIN0.752020-05-2108:451

1DRUG (ng/mL)126.441.861801011000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120306.446.44
9PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 110.75DAY 1 DOSE0.750.750.7545MIN0.752020-05-2108:451

1BIOMARKER (ng/mL)2576.984.343546002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203076.9876.98
10PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 111DAY 1 DOSE1111H12020-05-2109:001

1DRUG (ng/mL)129.802.282835001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120309.809.8
11PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 111DAY 1 DOSE1111H12020-05-2109:001

1BIOMARKER (ng/mL)2565.984.189386002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203065.9865.98
12PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 111.5DAY 1 DOSE1.51.51.51H30MIN1.52020-05-2109:301

1DRUG (ng/mL)1212.412.518406001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203012.4112.41
13PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 111.5DAY 1 DOSE1.51.51.51H30MIN1.52020-05-2109:301

1BIOMARKER (ng/mL)2571.674.272099002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203071.6771.67
14PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 112DAY 1 DOSE2222H22020-05-2110:001

1DRUG (ng/mL)129.212.219783001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120309.219.21
15PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 112DAY 1 DOSE2222H22020-05-2110:001

1BIOMARKER (ng/mL)2581.564.401337002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203081.5681.56
16PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 113DAY 1 DOSE3333H32020-05-2111:001

1DRUG (ng/mL)1217.402.856257001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203017.4017.4
17PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 113DAY 1 DOSE3333H32020-05-2111:001

1BIOMARKER (ng/mL)2571.204.265473002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203071.2071.2
18PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 114DAY 1 DOSE4444H42020-05-2112:001

1DRUG (ng/mL)1214.242.655828001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203014.2414.24
19PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 114DAY 1 DOSE4444H42020-05-2112:001

1BIOMARKER (ng/mL)2560.434.101539002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203060.4360.43
20PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 116DAY 1 DOSE6666H62020-05-2114:001

1DRUG (ng/mL)1216.982.831832001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203016.9816.98
21PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 116DAY 1 DOSE6666H62020-05-2114:001

1BIOMARKER (ng/mL)2584.684.438878002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203084.6884.68
22PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 118DAY 1 DOSE8888H82020-05-2116:001

1DRUG (ng/mL)1212.992.564352001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203012.9912.99
23PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 118DAY 1 DOSE8888H82020-05-2116:001

1BIOMARKER (ng/mL)2586.484.459932002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203086.4886.48
24PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 1112DAY 1 DOSE12121212H122020-05-2120:001

1DRUG (ng/mL)1219.512.970776001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203019.5119.51
25PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 11DAY 1112DAY 1 DOSE12121212H122020-05-2120:001

1BIOMARKER (ng/mL)2575.164.319583002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203075.1675.16
26PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 21DAY 2224DAY 1 DOSE2424241D242020-05-2108:002

1DRUG (ng/mL)1212.012.485983001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203012.0112.01
27PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 21DAY 2224DAY 1 DOSE2424241D242020-05-2108:002

1BIOMARKER (ng/mL)2589.634.495745002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203089.6389.63
28PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 31DAY 3348DAY 1 DOSE4848482D482020-05-2108:003

1DRUG (ng/mL)1210.182.320054001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203010.1810.18
29PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 31DAY 3348DAY 1 DOSE4848482D482020-05-2108:003

1BIOMARKER (ng/mL)2580.254.385157002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203080.2580.25
30PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 41DAY 4472DAY 1 DOSE7272723D722020-05-2108:004

1DRUG (ng/mL)128.902.185528001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120308.908.9
31PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 41DAY 4472DAY 1 DOSE7272723D722020-05-2108:004

1BIOMARKER (ng/mL)2578.604.364427002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203078.6078.6
32PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 51DAY 5596DAY 1 DOSE9696964D962020-05-2108:005

1DRUG (ng/mL)128.312.117239001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120308.318.31
33PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 51DAY 5596DAY 1 DOSE9696964D962020-05-2108:005

1BIOMARKER (ng/mL)2570.414.254365002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203070.4170.41
34PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 61DAY 66120DAY 1 DOSE1201201205D1202020-05-2108:006

1DRUG (ng/mL)126.981.943693001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120306.986.98
35PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 61DAY 66120DAY 1 DOSE1201201205D1202020-05-2108:006

1BIOMARKER (ng/mL)2575.254.320808002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203075.2575.25
36PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 71DAY 77144DAY 1 DOSE1441441446D1442020-05-2108:007

1DRUG (ng/mL)122.250.810999001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120302.252.25
37PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 71DAY 77144DAY 1 DOSE1441441446D1442020-05-2108:007

1BIOMARKER (ng/mL)2577.434.349329002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203077.4377.43
38PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 81DAY 88168DAY 1 DOSE1681681687D1682020-05-2108:008

1DRUG (ng/mL)122.500.91774001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120302.502.5
39PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 81DAY 88168DAY 1 DOSE1681681687D1682020-05-2108:008

1BIOMARKER (ng/mL)2585.564.449228002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203085.5685.56
40PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 91DAY 99192DAY 1 DOSE1921921928D1922020-05-2108:009

1DRUG (ng/mL)122.941.078083001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120302.942.94
41PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 91DAY 99192DAY 1 DOSE1921921928D1922020-05-2108:009

1BIOMARKER (ng/mL)2579.614.377099002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203079.6179.61
42PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 101DAY 1010216DAY 1 DOSE2162162169D2162020-05-2108:0010

1DRUG (ng/mL)123.191.161523001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120303.193.19
43PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 101DAY 1010216DAY 1 DOSE2162162169D2162020-05-2108:0010

1BIOMARKER (ng/mL)2561.604.120669002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203061.6061.6
44PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 111DAY 1111240DAY 1 DOSE24024024010D2402020-05-2108:0011

1DRUG (ng/mL)121.040.043502001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120301.041.04
45PROJECT-0011PROTOCOL-001110PROTOCOL-001-001-00137100100137001370011DAY 111DAY 1111240DAY 1 DOSE24024024010D2402020-05-2108:0011

1BIOMARKER (ng/mL)2573.214.293272002000100N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg Single Dose1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203073.2173.21
46PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 11-0.1DAY 1 MORNING DOSE-0.100PREDOSE02020-01-2107:541

1DRUG (ng/mL)12..011000011Y0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030.BLQ
47PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 11-0.1DAY 1 MORNING DOSE-0.100PREDOSE02020-01-2107:541

1BIOMARKER (ng/mL)25128.374.854907002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030128.37128.37
48PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 110DAY 1 MORNING DOSE000DOSE02020-01-2108:001

1TEST PRODUCT (mg)01
.11




N5050501270..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030

49PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 110.25DAY 1 MORNING DOSE0.250.250.2515MIN0.252020-01-2108:151

1DRUG (ng/mL)122.911.067237001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120302.912.91
50PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 110.25DAY 1 MORNING DOSE0.250.250.2515MIN0.252020-01-2108:151

1BIOMARKER (ng/mL)25103.274.637362002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030103.27103.27
51PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 110.5DAY 1 MORNING DOSE0.50.50.530MIN0.52020-01-2108:301

1DRUG (ng/mL)124.391.478924001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120304.394.39
52PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 110.5DAY 1 MORNING DOSE0.50.50.530MIN0.52020-01-2108:301

1BIOMARKER (ng/mL)25108.684.688433002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030108.68108.68
53PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 110.75DAY 1 MORNING DOSE0.750.750.7545MIN0.752020-01-2108:451

1DRUG (ng/mL)129.492.250409001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120309.499.49
54PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 110.75DAY 1 MORNING DOSE0.750.750.7545MIN0.752020-01-2108:451

1BIOMARKER (ng/mL)25113.544.732154002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030113.54113.54
55PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 111DAY 1 MORNING DOSE1111H12020-01-2109:001

1DRUG (ng/mL)1214.462.671443001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203014.4614.46
56PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 111DAY 1 MORNING DOSE1111H12020-01-2109:001

1BIOMARKER (ng/mL)2597.324.577994002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203097.3297.32
57PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 111.5DAY 1 MORNING DOSE1.51.51.51H30MIN1.52020-01-2109:301

1DRUG (ng/mL)1218.302.907014001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203018.3018.3
58PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 111.5DAY 1 MORNING DOSE1.51.51.51H30MIN1.52020-01-2109:301

1BIOMARKER (ng/mL)25105.714.660707002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030105.71105.71
59PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 112DAY 1 MORNING DOSE2222H22020-01-2110:001

1DRUG (ng/mL)1213.582.608391001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203013.5813.58
60PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 112DAY 1 MORNING DOSE2222H22020-01-2110:001

1BIOMARKER (ng/mL)25120.294.789945002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030120.29120.29
61PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 113DAY 1 MORNING DOSE3333H32020-01-2111:001

1DRUG (ng/mL)1225.663.244865001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203025.6625.66
62PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 113DAY 1 MORNING DOSE3333H32020-01-2111:001

1BIOMARKER (ng/mL)25105.014.654081002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030105.01105.01
63PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 114DAY 1 MORNING DOSE4444H42020-01-2112:001

1DRUG (ng/mL)1221.003.044436001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203021.0021
64PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 114DAY 1 MORNING DOSE4444H42020-01-2112:001

1BIOMARKER (ng/mL)2589.134.490147002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203089.1389.13
65PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 116DAY 1 MORNING DOSE6666H62020-01-2114:001

1DRUG (ng/mL)1225.043.22044001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203025.0425.04
66PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 116DAY 1 MORNING DOSE6666H62020-01-2114:001

1BIOMARKER (ng/mL)25124.904.827486002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030124.90124.9
67PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 118DAY 1 MORNING DOSE8888H82020-01-2116:001

1DRUG (ng/mL)1219.162.95296001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203019.1619.16
68PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 118DAY 1 MORNING DOSE8888H82020-01-2116:001

1BIOMARKER (ng/mL)25127.554.84854002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030127.55127.55
69PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 1112DAY 1 MORNING DOSE12121212H122020-01-2120:001

1DRUG (ng/mL)1228.773.359384001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203028.7728.77
70PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 11DAY 1112DAY 1 MORNING DOSE12121212H122020-01-2120:001

1BIOMARKER (ng/mL)25110.854.708191002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030110.85110.85
71PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 22DAY 2224DAY 1 AFTERNOON DOSE122412PREDOSE02020-01-2208:002

1DRUG (ng/mL)1217.722.874591001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203017.7217.72
72PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 22DAY 2224DAY 1 AFTERNOON DOSE122412PREDOSE02020-01-2208:002

1BIOMARKER (ng/mL)25132.204.884353002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030132.20132.2
73PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 33DAY 3348DAY 2 AFTERNOON DOSE124812PREDOSE02020-01-2308:003

1DRUG (ng/mL)1217.012.833753001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203017.0117.01
74PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 33DAY 3348DAY 2 AFTERNOON DOSE124812PREDOSE02020-01-2308:003

1BIOMARKER (ng/mL)25118.364.773765002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030118.36118.36
75PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 44DAY 4472DAY 3 AFTERNOON DOSE127212PREDOSE02020-01-2408:004

1DRUG (ng/mL)1217.322.851861001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203017.3217.32
76PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 44DAY 4472DAY 3 AFTERNOON DOSE127212PREDOSE02020-01-2408:004

1BIOMARKER (ng/mL)25115.944.753035002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030115.94115.94
77PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5595.9DAY 4 AFTERNOON DOSE11.069612PREDOSE02020-01-2507:545

2DRUG (ng/mL)1217.322.851861001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203017.3217.32
78PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5595.9DAY 4 AFTERNOON DOSE11.069612PREDOSE02020-01-2507:545

2BIOMARKER (ng/mL)25128.374.854907002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030128.37128.37
79PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5595.9DAY 5 MORNING DOSE095.90DOSE02020-01-250.3333335

2TEST PRODUCT (mg)01
.11





505050000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030

80PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5596.25DAY 5 MORNING DOSE0.2596.250.2515MIN0.252020-01-2508:155

2DRUG (ng/mL)1219.912.991088001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203019.9119.91
81PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5596.25DAY 5 MORNING DOSE0.2596.250.2515MIN0.252020-01-2508:155

2BIOMARKER (ng/mL)25103.274.637362002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030103.27103.27
82PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5596.5DAY 5 MORNING DOSE0.596.50.530MIN0.52020-01-2508:305

2DRUG (ng/mL)1221.393.06284001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203021.3921.39
83PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5596.5DAY 5 MORNING DOSE0.596.50.530MIN0.52020-01-2508:305

2BIOMARKER (ng/mL)25108.684.688433002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030108.68108.68
84PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5596.75DAY 5 MORNING DOSE0.7596.750.7545MIN0.752020-01-2508:455

2DRUG (ng/mL)1226.493.276828011000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203026.4926.49
85PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5596.75DAY 5 MORNING DOSE0.7596.750.7545MIN0.752020-01-2508:455

2BIOMARKER (ng/mL)25113.544.732154002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030113.54113.54
86PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5597DAY 5 MORNING DOSE19711H12020-01-2509:005

2DRUG (ng/mL)1231.463.448743001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203031.4631.46
87PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5597DAY 5 MORNING DOSE19711H12020-01-2509:005

2BIOMARKER (ng/mL)2597.324.577994002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203097.3297.32
88PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5597.5DAY 5 MORNING DOSE1.597.51.51H30MIN1.52020-01-2509:305

2DRUG (ng/mL)1235.303.563942001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203035.3035.3
89PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5597.5DAY 5 MORNING DOSE1.597.51.51H30MIN1.52020-01-2509:305

2BIOMARKER (ng/mL)25105.714.660707002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030105.71105.71
90PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5598DAY 5 MORNING DOSE29822H22020-01-2510:005

2DRUG (ng/mL)1230.583.420254001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203030.5830.58
91PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5598DAY 5 MORNING DOSE29822H22020-01-2510:005

2BIOMARKER (ng/mL)252120.294.789945002000101Y0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120302120.292120.29
92PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5599DAY 5 MORNING DOSE39933H32020-01-2511:005

2DRUG (ng/mL)1242.663.753221001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203042.6642.66
93PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 5599DAY 5 MORNING DOSE39933H32020-01-2511:005

2BIOMARKER (ng/mL)25105.014.654081002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030105.01105.01
94PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 55100DAY 5 MORNING DOSE410044H42020-01-2512:005

2DRUG (ng/mL)1238.003.637538001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203038.0038
95PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 55100DAY 5 MORNING DOSE410044H42020-01-2512:005

2BIOMARKER (ng/mL)2589.134.490147002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203089.1389.13
96PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 55102DAY 5 MORNING DOSE610266H62020-01-2514:005

2DRUG (ng/mL)1242.043.738601001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203042.0442.04
97PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 55102DAY 5 MORNING DOSE610266H62020-01-2514:005

2BIOMARKER (ng/mL)25124.904.827486002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030124.90124.9
98PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 55104DAY 5 MORNING DOSE810488H82020-01-2516:005

2DRUG (ng/mL)1236.163.588025001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203036.1636.16
99PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 55104DAY 5 MORNING DOSE810488H82020-01-2516:005

2BIOMARKER (ng/mL)25127.554.84854002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030127.55127.55
100PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 55108DAY 5 MORNING DOSE121081212H122020-01-2520:005

2DRUG (ng/mL)1245.773.823661001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203045.7745.77
101PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 55DAY 55108DAY 5 MORNING DOSE121081212H122020-01-2520:005

2BIOMARKER (ng/mL)25110.854.708191002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030110.85110.85
102PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 66DAY 66120DAY 5 MORNING DOSE241202424H242020-01-2608:006

2DRUG (ng/mL)1217.302.8508001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203017.3017.3
103PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 66DAY 66120DAY 5 MORNING DOSE241202424H242020-01-2608:006

2BIOMARKER (ng/mL)25110.994.709416002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030110.99110.99
104PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 77DAY 77144DAY 5 MORNING DOSE48144482D482020-01-2708:007

2DRUG (ng/mL)123.321.199607001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120303.323.32
105PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 77DAY 77144DAY 5 MORNING DOSE48144482D482020-01-2708:007

2BIOMARKER (ng/mL)25114.204.737937002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030114.20114.2
106PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 88DAY 88168DAY 5 MORNING DOSE72168723D722020-01-2808:008

2DRUG (ng/mL)123.691.306348001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120303.693.69
107PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 88DAY 88168DAY 5 MORNING DOSE72168723D722020-01-2808:008

2BIOMARKER (ng/mL)25126.204.837836002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030126.20126.2
108PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 99DAY 99192DAY 5 MORNING DOSE96192964D962020-01-2908:009

2DRUG (ng/mL)124.331.466691001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120304.334.33
109PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 99DAY 99192DAY 5 MORNING DOSE96192964D962020-01-2908:009

2BIOMARKER (ng/mL)25117.414.765707002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030117.41117.41
110PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 1010DAY 1010216DAY 5 MORNING DOSE1202161205D1202020-01-3008:0010

2DRUG (ng/mL)124.711.550131001000010N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120304.714.71
111PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 1010DAY 1010216DAY 5 MORNING DOSE1202161205D1202020-01-3008:0010

2BIOMARKER (ng/mL)2590.864.509277002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203090.8690.86
112PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 1111DAY 1111240DAY 5 MORNING DOSE1442401446D1442020-01-3108:0011

2DRUG (ng/mL)120.000.43211001000011Y0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120300.00BLQ
113PROJECT-0011PROTOCOL-002210PROTOCOL-002-001-00237200100237002370011DAY 1111DAY 1111240DAY 5 MORNING DOSE1442401446D1442020-01-3108:0011

2BIOMARKER (ng/mL)25107.974.68188002000100N0N50500000..TABLET1ORAL1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1DOSE ESCALATION11BEFORE CROSSOVERTEST DRUG 100 mg BID1TEST DRUG 100 mg BID1TEST DRUG 100 mg BID1707017024.21.8130M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030107.97107.97
114PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 11-0.1CYCLE 1 DAY 1 DOSE-0.100PREDOSE02020-09-2107:541

1DRUG (ng/mL)12..011000011Y0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030
LLOQ <= 1
115PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 110CYCLE 1 DAY 1 DOSE000DOSE02020-09-2108:001

1TEST PRODUCT (mg)01..111000010N0N505050000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030

116PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 110.25CYCLE 1 DAY 1 DOSE0.250.250.2515MIN0.252020-09-2108:151

1DRUG (ng/mL)121.280.799881001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120301.281.28
117PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 110.5CYCLE 1 DAY 1 DOSE0.50.50.530MIN0.52020-09-2108:301

1DRUG (ng/mL)121.931.211567001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120301.931.93
118PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 110.75CYCLE 1 DAY 1 DOSE0.750.750.7545MIN0.752020-09-2108:451

1DRUG (ng/mL)124.171.983053011000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120304.174.17
119PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 111CYCLE 1 DAY 1 DOSE1111H12020-09-2109:001

1DRUG (ng/mL)126.372.404086001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120306.376.37
120PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 111.5CYCLE 1 DAY 1 DOSE1.51.51.51H30MIN1.52020-09-2109:301

1DRUG (ng/mL)128.062.639658001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120308.068.06
121PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 112CYCLE 1 DAY 1 DOSE2222H22020-09-2110:001

1DRUG (ng/mL)125.972.341034001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120305.975.97
122PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 113CYCLE 1 DAY 1 DOSE3333H32020-09-2111:001

1DRUG (ng/mL)1211.292.977508001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203011.2911.29
123PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 114CYCLE 1 DAY 1 DOSE4444H42020-09-2112:001

1DRUG (ng/mL)129.242.777079001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120309.249.24
124PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 116CYCLE 1 DAY 1 DOSE6666H62020-09-2114:001

1DRUG (ng/mL)1211.022.953083001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203011.0211.02
125PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 118CYCLE 1 DAY 1 DOSE8888H82020-09-2116:001

1DRUG (ng/mL)128.442.685603001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120308.448.44
126PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 1112CYCLE 1 DAY 1 DOSE12121212H122020-09-2120:001

1DRUG (ng/mL)1212.663.092027001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203012.6612.66
127PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 11CYCLE 1 DAY 2223.917CYCLE 1 DAY 1 DOSE23.91724241D242020-09-2207:552

1DRUG (ng/mL)127.802.607234001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120307.807.8
128PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 21CYCLE 1 DAY 210CYCLE 1 DAY 2 DOSE0240DOSE02020-09-2208:002

1TEST PRODUCT (mg)01
.111000010N0N505050000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030

129PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 21CYCLE 1 DAY 1124.45CYCLE 1 DAY 2 DOSE0.4524.50.530MIN0.52020-09-2208:272

1DRUG (ng/mL)122.280.824175001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120302.282.28
130PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 21CYCLE 1 DAY 1126CYCLE 1 DAY 2 DOSE22622H22020-09-2210:002

1DRUG (ng/mL)127.051.953028001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120307.057.05
131PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 21CYCLE 1 DAY 1132CYCLE 1 DAY 2 DOSE83288H82020-09-2216:002

1DRUG (ng/mL)129.952.297573001000010N0N50500000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120309.959.95
132PROJECT-0011PROTOCOL-005310PROTOCOL-005-003-00485500300485004850033CYCLE 1 DAY 31CYCLE 1 DAY 3148.17CYCLE 1 DAY 3 DOSE0480DOSE02020-09-2308:103

1TEST PRODUCT (mg)01..111000010N0N505050000..TABLET1ORAL1TEST DRUG 50 mg1TEST DRUG 50 mg1CYCLE 111CYCLE 1TEST DRUG 50 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 50 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030

133PROJECT-0011PROTOCOL-005320PROTOCOL-005-003-00485500300485004850033CYCLE 2 DAY 11CYCLE 2 DAY 11264CYCLE 2 DAY 1 DOSE02640DOSE02020-10-0208:0012

1TEST PRODUCT (mg)01..111000010N0N7575752450..TABLET1ORAL1TEST DRUG 75 mg1TEST DRUG 75 mg1DOSE ESCALATION11CYCLE 2TEST DRUG 75 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 75 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030

134PROJECT-0011PROTOCOL-005320PROTOCOL-005-003-00485500300485004850033CYCLE 2 DAY 71CYCLE 2 DAY 71408CYCLE 2 DAY 7 DOSE04080DOSE02020-10-0808:0018

1TEST PRODUCT (mg)01..111000010N0N1001001002490..TABLET1ORAL1TEST DRUG 100 mg1TEST DRUG 100 mg1DOSE ESCALATION11CYCLE 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030

135PROJECT-0011PROTOCOL-005320PROTOCOL-005-003-00485500300485004850033CYCLE 2 DAY 171CYCLE 2 DAY 171648CYCLE 2 DAY 17 DOSE06480DOSE02020-10-1808:0028

1TEST PRODUCT (mg)01..111000010N0N100100100000..TABLET1ORAL1TEST DRUG 100 mg1TEST DRUG 100 mg1DOSE ESCALATION11CYCLE 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030

136PROJECT-0011PROTOCOL-005320PROTOCOL-005-003-00485500300485004850033CYCLE 2 DAY 181CYCLE 2 DAY 181671.83CYCLE 2 DAY 17 DOSE-0.16720PREDOSE02020-10-1907:5029

1DRUG (ng/mL)124.951.599388011000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg1TEST DRUG 100 mg1DOSE ESCALATION11CYCLE 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120304.954.95
137PROJECT-0011PROTOCOL-005320PROTOCOL-005-003-00485500300485004850033CYCLE 2 DAY 181CYCLE 2 DAY 181672CYCLE 2 DAY 18 DOSE06720DOSE02020-10-1908:0029

1TEST PRODUCT (mg)01..111000010N0N100100100000..TABLET1ORAL1TEST DRUG 100 mg1TEST DRUG 100 mg1DOSE ESCALATION11CYCLE 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.215001009012030..
138PROJECT-0011PROTOCOL-005320PROTOCOL-005-003-00485500300485004850033CYCLE 2 DAY 181CYCLE 2 DAY 181672.5CYCLE 2 DAY 18 DOSE0.5672.50.530MIN0.52020-10-1908:3029

1DRUG (ng/mL)128.032.083185001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg1TEST DRUG 100 mg1DOSE ESCALATION11CYCLE 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.2150010090120308.038.03
139PROJECT-0011PROTOCOL-005320PROTOCOL-005-003-00485500300485004850033CYCLE 2 DAY 181CYCLE 2 DAY 181674CYCLE 2 DAY 18 DOSE267422H22020-10-1910:0029

1DRUG (ng/mL)1224.833.212053001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg1TEST DRUG 100 mg1DOSE ESCALATION11CYCLE 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203024.8324.83
140PROJECT-0011PROTOCOL-005320PROTOCOL-005-003-00485500300485004850033CYCLE 2 DAY 181CYCLE 2 DAY 181680.33CYCLE 2 DAY 18 DOSE868088H82020-10-1916:2029

1DRUG (ng/mL)1235.053.556776001000010N0N1001000000..TABLET1ORAL1TEST DRUG 100 mg1TEST DRUG 100 mg1DOSE ESCALATION11CYCLE 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1696917522.51.8440M1WHITE1Non-Hispanic1North America1UNITED STATES11.21500100901203035.0535.05
141PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY11-0.1DAY 1 DOSE-0.100PREDOSE02021-01-0707:541

1DRUG (ng/mL)12..011000011Y0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.12140
LLOQ <= 1
142PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY110DAY 1 DOSE000DOSE02021-01-0708:0012021-01-0708:301TEST PRODUCT (mg)02..111000010N0N1001001000002000.5IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.12140

143PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY110.5DAY 1 DOSE0.50.50.530MIN0.52021-01-0708:301

1DRUG (ng/mL)1214.762.691921001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214014.7614.76
144PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY111.083DAY 1 DOSE1.083111H12021-01-0709:031

1DRUG (ng/mL)1213.282.586259001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214013.2813.28
145PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY113DAY 1 DOSE3333H32021-01-0711:001

1DRUG (ng/mL)1212.532.528126001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214012.5312.53
146PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY116DAY 1 DOSE6666H62021-01-0714:001

1DRUG (ng/mL)1213.692.616666001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214013.6913.69
147PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY118.167DAY 1 DOSE8.167888H82021-01-0716:061

1DRUG (ng/mL)1212.322.511224001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214012.3212.32
148PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY1112DAY 1 DOSE12121212H122021-01-0720:001

1DRUG (ng/mL)128.622.154085001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.121408.628.62
149PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY1124.5DAY 1 DOSE24.5242424H242021-01-0808:302

1DRUG (ng/mL)126.341.846879001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.121406.346.34
150PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY1148DAY 1 DOSE48484848H482021-01-0908:003

1DRUG (ng/mL)122.320.841567001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.121402.322.32
151PROJECT-0011PROTOCOL-006410PROTOCOL-006-001-00013600100013000130011DAY11DAY1172DAY 1 DOSE72727272H722021-01-1008:004

1DRUG (ng/mL)12..011000011Y0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION11PERIOD 1TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1697017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.12140
LLOQ <= 1
152PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY142DAY142336DAY 14 DOSE03360DOSE02021-01-2108:00142021-01-2108:301TEST PRODUCT (mg)02..111000010N0N1001001000002000.5IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1727017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.12140

153PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY153DAY153360DAY 15 DOSE03600DOSE02021-01-2208:00152021-01-2208:301TEST PRODUCT (mg)02..111000010N0N10010010024502000.5IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1727017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.12140

154PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214503.9DAY 20 DOSE-0.15040PREDOSE02021-01-2807:5421

1DRUG (ng/mL)129.662.267994001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1727017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.121409.669.66
155PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214504DAY 21 DOSE05040DOSE02021-01-2808:00212021-01-2808:301TEST PRODUCT (mg)02..111000010N0N1001001000002000.5IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.12140

156PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214504.583DAY 21 DOSE0.583504.50.530MIN0.52021-01-2808:3621

1DRUG (ng/mL)1224.2883.189982001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214024.28824.288
157PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214505DAY 21 DOSE150511H12021-01-2809:0021

1DRUG (ng/mL)1222.6763.121307001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214022.67622.676
158PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214507DAY 21 DOSE350733H32021-01-2811:0021

1DRUG (ng/mL)1221.3983.063297001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214021.39821.398
159PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214510.167DAY 21 DOSE6.16751066H62021-01-2814:0621

1DRUG (ng/mL)1221.7653.080303001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214021.76521.765
160PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214512DAY 21 DOSE851288H82021-01-2816:0021

1DRUG (ng/mL)1219.8672.98906001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214019.86719.867
161PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214516.167DAY 21 DOSE12.1675161212H122021-01-2820:0621

1DRUG (ng/mL)1228.8953.363669001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214028.89528.895
162PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214528DAY 21 DOSE245282424H242021-01-2908:0022

1DRUG (ng/mL)1215.112.715357001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.1214015.1115.11
163PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214552DAY 21 DOSE485524848H482021-01-3008:0023

1DRUG (ng/mL)126.341.846879001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.121406.346.34
164PROJECT-0011PROTOCOL-006420PROTOCOL-006-001-00013600100013000130011DAY214DAY214578DAY 21 DOSE745767272H722021-01-3110:0024

1DRUG (ng/mL)122.320.841567001000010N0N1001000000..IV2IV2TEST DRUG 100 mg2TEST DRUG 100 mg1DOSE ESCALATION12PERIOD 2TEST DRUG 100 mg1TEST DRUG 100 mg Single Dose1TEST DRUG 100 mg1717017522.51.8448M1BLACK OR AFRICAN AMERICAN2Non-Hispanic1North America1UNITED STATES11.07140084821.121402.322.32
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