In Vivo Crossover Design (Latin Square)

TOBA-207 - Getting issue details... STATUS

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.

TOBA-216 - Getting issue details... STATUS

te.xpt

Row	STUDYID	DOMAIN	ETCD	ELEMENT	TESTRL	TEENRL	TEDUR
1	TDM5	TE	SCRN	Screen	Start of Preexposure	10 days after start of Element	P10D
2	TDM5	TE	CONTROL	Vehicle Control	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

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

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	25	SPLANSUB	Planned Number of Subjects	20

$warningHtml

« In Vivo Study With Multiple Experimental Factors

In vivo Studies »

Page tree

In Vivo Crossover Design (Latin Square)