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 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 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 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 product exposure elements, indicating whether they follow a product 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 a product 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 intervention article) 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
DOS
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
ITVDOSU
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
ITVDOS
Dose Level
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
ITVDOSU
Dose Units
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
ITVDOS
Dose Level
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
ITVDOSU
Dose Units
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
ITVDOS
Dose Level
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
ITVDOSU
Dose Units
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
