drugset / Trial / NCT02411162

A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream

NCT02411162

Phase 1 Completed 15 enrolled Stiefel, a GSK Company
Non-randomizedSingle-groupOpen-labelBasic science

Summary

This will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will assess the residence time in human skin . The primary objective is to evaluate the residency time in skin following topical application of two formulations of GSK2894512 Cream. The total study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of post treatment period and 1 day of follow up. The screening period will be up to 28 days prior to Baseline (Day 1).

Timeline

Start
2015-07-07
Primary completion
2015-09-24
Completion
2015-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Tapinarof Other / unclassified 1 % Topical

Indications