Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT03436160
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2018-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Assessing Pharmacokinetics and Bioavailability of Three Novel Triazine Compounds
Sponsor:
U.S. Army Medical Research and Development Command
Organization:
Study Overview
Official Title:
Exploratory Microdose Study Assessing Pharmacokinetics and Bioavailability of Three Novel Triazine Compounds
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Open-label, randomized, microdose study
Detailed Description:
This is an open-label, randomized, fixed-sequence, microdose study of three Carbon-14 radio labeled (14C) triazine compounds WR826647, WR909388, WR909390 designed in accordance with ICH Guidance for Industry M3(R2) (ICH 2009). Subjects will be randomized to one of three groups to receive 100 mcg WR826647, WR909388, or WR909390 at an exposure no greater than 250 nCi per dose, administered both IV (bolus) and PO with a six half-life wash-out period between IV and PO administration. Interim analyses will be done at Day 14 following the IV dosing groups in order to assess half-lives of the three compounds to ensure the wash-out period between IV and PO dosing is at least six half-lives long.
Pharmacokinetic parameters of the 3 compounds will be calculated from the plasma-time data using Phoenix WinNonlin version 6.3 or higher, and descriptive statistics assessed using SAS version 9.3 or higher. No statistical significance inferences will be made. An analysis of variance (ANOVA) will be performed on the natural logarithm (ln) transformed dose-adjusted AUCinf to estimate the bioavailability. The sample size of 6 subjects per group is considered adequate to obtain useful data to compute descriptive statistics. Interim analyses will be done after the IV dosing groups in order to assess half-lives of the 3 compounds to ensure the wash-out period between IV bolus and oral dosing is at least 6 half-lives long.
Pharmacokinetic parameters of the 3 compounds will be calculated from the plasma-time data using Phoenix WinNonlin version 6.3 or higher, and descriptive statistics assessed using SAS version 9.3 or higher. No statistical significance inferences will be made. An analysis of variance (ANOVA) will be performed on the natural logarithm (ln) transformed dose-adjusted AUCinf to estimate the bioavailability. The sample size of 6 subjects per group is considered adequate to obtain useful data to compute descriptive statistics. Interim analyses will be done after the IV dosing groups in order to assess half-lives of the 3 compounds to ensure the wash-out period between IV bolus and oral dosing is at least 6 half-lives long.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: