This example assumes a crossover design in which the applicant-defined protocol specifies the following information. All subjects are to be screened for 10 days prior to randomization into 4 protocol groups:
Group 1 is a control group of 20 subjects, 10 male and 10 female, which are to be dosed with vehicle once per day for 14 days, given a 7-day rest period, dosed again with vehicle once per day for 14 days, given a second 7-day rest period, and dosed with vehicle once per day for the final 14 days.
Group 2 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 50 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 800 mg/kg once per day for 14 days, given a second 7-day rest period, and dosed at 400 mg/kg of product once per day for the final 14 days.
Group 3 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 400 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 50 mg/kg of product once per day for 14 days, given a second 7-day rest period, and dosed at 800 mg/kg of product once per day for the final 14 days.
Group 4 is a group of 20 subjects, 10 male and 10 female, which are to be dosed at 800 mg/kg of product/intervention article once per day for 14 days, given a 7-day rest period, dosed at 400 mg/kg of product once per day for 14 days, given a second 7-day rest period, and dosed at 50 mg/kg of product once per day for the final 14 days.
There are no other experimental factors of interest specified in the study design.
Figure. Example Trial 5 Design
Trial Elements
This example shows the start and end rules and durations for the different exposure elements, indicating whether they follow an exposure or nonexposure element.
First dosing with vehicle control following a nonexposure Element
14 days after start of Element
P14D
3
TDM5
TE
REST
Rest for 7 days
1 day after last dose in an exposure Element
7 days after start of Element
P7D
4
TDM5
TE
50A
50 mg/kg Drug A, once daily
First dosing with 50 mg/kg Drug a following a nonexposure Element
14 days after start of Element
P14D
5
TDM5
TE
400A
400 mg/kg Drug A, once daily
First dosing with 400 mg/kg Drug a following a nonexposure Element
14 days after start of Element
P14D
6
TDM5
TE
800A
800 mg/kg Drug A, once daily
First dosing with 800 mg/kg Drug a following a nonexposure Element
14 days after start of Element
P14D
$warningHtml
Trial Arms
Based upon the description, there are 4 trial arms.
ta.xpt
ta.xpt
Row
STUDYID
DOMAIN
ARMCD
ARM
TAETORD
ETCD
ELEMENT
TABRANCH
EPOCH
1
TDM5
TA
1
Control
1
SCRN
Screen
Randomized to Group 1
PRE-EXPOSURE
2
TDM5
TA
1
Control
2
CONTROL
Vehicle Control
EXPOSURE
3
TDM5
TA
1
Control
3
REST
Rest for 7 days
WASHOUT
4
TDM5
TA
1
Control
4
CONTROL
Vehicle Control
EXPOSURE
5
TDM5
TA
1
Control
5
REST
Rest for 7 days
WASHOUT
6
TDM5
TA
1
Control
6
CONTROL
Vehicle Control
EXPOSURE
7
TDM5
TA
2
50-800-400
1
SCRN
Screen
Randomized to Group 2
PRE-EXPOSURE
8
TDM5
TA
2
50-800-400
2
50A
50 mg/kg Drug A
EXPOSURE
9
TDM5
TA
2
50-800-400
3
REST
Rest for 7 days
WASHOUT
10
TDM5
TA
2
50-800-400
4
800A
800 mg/kg Drug A
EXPOSURE
11
TDM5
TA
2
50-800-400
5
REST
Rest for 7 days
WASHOUT
12
TDM5
TA
2
50-800-400
6
400A
400 mg/kg Drug A
EXPOSURE
13
TDM5
TA
3
400-50-800
1
SCRN
Screen
Randomized to Group 3
PRE-EXPOSURE
14
TDM5
TA
3
400-50-800
2
400A
400 mg/kg Drug A
EXPOSURE
15
TDM5
TA
3
400-50-800
3
REST
Rest for 7 days
WASHOUT
16
TDM5
TA
3
400-50-800
4
50A
50 mg/kg Drug A
EXPOSURE
17
TDM5
TA
3
400-50-800
5
REST
Rest for 7 days
WASHOUT
18
TDM5
TA
3
400-50-800
6
800A
800 mg/kg Drug A
EXPOSURE
19
TDM5
TA
4
800-400-50
1
SCRN
Screen
Randomized to Group 4
PRE-EXPOSURE
20
TDM5
TA
4
800-400-50
2
800A
800 mg/kg Drug A
EXPOSURE
21
TDM5
TA
4
800-400-50
3
REST
Rest for 7 days
WASHOUT
22
TDM5
TA
4
800-400-50
4
400A
400 mg/kg Drug A
EXPOSURE
23
TDM5
TA
4
800-400-50
5
REST
Rest for 7 days
WASHOUT
24
TDM5
TA
4
800-400-50
6
50A
50 mg/kg Drug A
EXPOSURE
$warningHtml
Trial Sets
In this example, there are 4 trial sets. The experimental factors considered are type of exposure (vehicle control or product) and sequencing of exposure levels. The applicant is providing the arm code, applicant-defined group code, group label, control type, dose level and units, and planned number of subjects (total) only.
tx.xpt
tx.xpt
Row
STUDYID
DOMAIN
SETCD
SET
TXSEQ
TXPARMCD
TXPARM
TXVAL
1
TDM5
TX
1
Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between
1
ARMCD
Arm Code
1
2
TDM5
TX
1
Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between
2
SPGRPCD
Applicant-Defined Group Code
1
3
TDM5
TX
1
Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between
3
GRPLBL
Group Label
Group 1, Control
4
TDM5
TX
1
Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between
4
TCNTRL
Control Type
VEHICLE CONTROL
5
TDM5
TX
1
Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between
5
TRTDOS
Dose Level
0
6
TDM5
TX
1
Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between
6
TRTDOSU
Dose Units
mg/kg/day
7
TDM5
TX
1
Group 1, (Vehicle Control Name) once daily for each of 3 dosing periods of 14 days each with 7-day rests between
7
SPLANSUB
Planned Number of Subjects
20
8
TDM5
TX
2
Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between
8
ARMCD
Arm Code
2
9
TDM5
TX
2
Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between
9
SPGRPCD
Applicant-Defined Group Code
2
10
TDM5
TX
2
Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between
10
GRPLBL
Group Label
Group 2, 50-800-400 mg/kg/day
11
TDM5
TX
2
Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between
11
ITVCONC
Concentration of Intervention Article
SEE PROTOCOL
12
TDM5
TX
2
Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between
12
ITVCONCU
Concentration Unit for Intervention Article
SEE PROTOCOL
13
TDM5
TX
2
Group 2, (Intervention Name) once daily dosing in sequence: 50-800-400 mg/kg (14 days each) with 7-day rests between
13
SPLANSUB
Planned Number of Subjects
20
14
TDM5
TX
3
Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between
14
ARMCD
Arm Code
3
15
TDM5
TX
3
Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between
15
SPGRPCD
Applicant-Defined Group Code
3
16
TDM5
TX
3
Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between
16
GRPLBL
Group Label
Group 3, 400-50-800 mg/kg/day
17
TDM5
TX
3
Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between
17
ITVCONC
Concentration of Intervention Article
SEE PROTOCOL
18
TDM5
TX
3
Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between
18
ITVCONCU
Concentration Unit for Intervention Article
SEE PROTOCOL
19
TDM5
TX
3
Group 3, (Intervention Name) once daily dosing in sequence: 400-50-800 mg/kg (14 days each) with 7-day rests between
19
SPLANSUB
Planned Number of Subjects
20
20
TDM5
TX
4
Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between
20
ARMCD
Arm Code
4
21
TDM5
TX
4
Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between
21
SPGRPCD
Applicant-Defined Group Code
4
22
TDM5
TX
4
Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between
22
GRPLBL
Group Label
Group 4, 800-400-50 mg/kg/day
23
TDM5
TX
4
Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between
23
ITVCONC
Concentration of Intervention Article
SEE PROTOCOL
24
TDM5
TX
4
Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between
24
ITVCONCU
Concentration Unit for Intervention Article
SEE PROTOCOL
25
TDM5
TX
4
Group 4, (Intervention Name) once daily dosing in sequence: 800-400-50 mg/kg (14 days each) with 7-day rests between
