NCT02411162

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

Skin Residency Study of Topically Applied GSK2894512 Cream in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Combination therapy GSK2894512 Cream A + GSK2894512 Cream B	GSK2894512 Cream A, 1% (10mg/g) will be topically applied daily for 7 days as a thin layer onto an area of the volar region of one forearm (up to 1.5% body surface area) and GSK2894512 Cream B, 1% (10mg/g), will be topically applied daily for 7 days to the opposite forearm from Cream A, onto an area of the volar region of one forearm (up to 1.5% body surface area). Both the creams will be weighed to deliver approximately 3mg drug per 1cm\^2 of skin.
DRUG	Combination therapy Vehicle Cream A + Vehicle Cream B	Vehicle creams A and B will be supplied in individual tubes. Both the creams will be topically applied on Day 1 only to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied.

Timeline

• Start date: 2015-07-07
• Primary completion: 2015-09-24
• Completion: 2015-09-24
• First posted: 2015-04-08
• Last updated: 2017-05-09

Locations

1 site across 1 country: United States