Clinical Trial: A Study to Evaluate the Pharmacokinetics of Benzoic Acid and Hippuric Acid After Topical Administration of GSK2585823 in Japanese Subjects With Acne Vulgaris
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study to Evaluate the Pharmacokinetics of Benzoic Acid and Hippuric Acid After Topical Administration of GSK2585823 in Japanese Subjects With Acne Vulgaris
Brief Summary: This is a Phase 1, single-center, open-label study to evaluate the pharmacokinetics of the BPO metabolites benzoic acid and hippuric acid with 7-day repeat application of GSK2585823 in subjects with acne vulgaris
Detailed Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome: Comparison of plasma benzoic acid and hippuric acid pharmacokinetics between pre-application and post-application (7-days repeat) of GSK2585823 [ Time Frame: Participants will be followed up to 7 days after the last application, an expected average of 15 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Comparison of urine benzoic acid and hippuric acid [ Time Frame: Participants will be followed up to 7 days after the last application, an expected average of 15 days ]Urine PK sampling time frame:0-4, 4-8, 8-12 hours post-dose (Day 1 and Day 8). Parameters: Renal clearance (CLr), amount of elimination (Ae) and fraction of elimination (fe), if calculable.
- change from baseline in vital signs, ECGs, clinical laboratory tests [ Time Frame: Day -1 - Day 15 ]Vital signs, ECGs, clinical laboratory tests
- Collection of adverse events [ Time Frame: Participants will be followed up to 7 days after the last application, an expected average of 15 days ]Number of adverse events
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: January 26, 2012
Date Started: February 2012
Date Completion:
Last Updated: November 20, 2016
Last Verified: November 2016