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 ]

Blood PK sampling time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9,12hours post-dose (Day 1 and Day 8). Parameters: Maximum observed concentration(Cmax),Time of occurrence of Cmax (tmax), Area under the concentration-time curve from time zero (pre-dose) extrapolated to last time (AUC0-last), Area under the concentration-time curve from time zero (pre-dose) to 12 hours of quantifiable concentration within a subject across all treatments (AUC0-12) and Terminal phase half-life (t1/2,) for both benzoic acid and hippuric acid, after multiple application of GSK2585823, if calculable


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