Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT03436160
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.
Study:
NCT03436160
Study Brief:
Protocol Section:
NCT03436160