NCT03201978

A Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of GSK2894512 in Healthy Adult Subjects

A Randomized, Double-Blind, Vehicle-Controlled, 3-Period, Sequential Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Repeat Topical Applications of GSK2894512 Cream in Healthy Adult Participants

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

GSK2894512 (trans-isomer) is a fully synthetic, non-steroidal anti-inflammatory agent. This study is being conducted to evaluate the PK, safety and tolerability of GSK2894512 cream, 1 percent administered topically to healthy adult subjects. PK parameters obtained in this study will be used to support the design of future maximum use PK (MUPK) studies in subjects with atopic dermatitis (AD) and plaque psoriasis or psoriasis (PSO). This is a phase 1, randomized, double-blind, vehicle-controlled, 3-period, sequential, inpatient study consists of a Screening visit, 3 treatment periods and a follow-up visit. GSK2894512 cream, 1 percent (or matching vehicle) will be administered sequentially in the treatment periods. Period 1 will include once daily repeated topical applications on approximately 5000 centimeter (cm) \^2 intact non-occluded skin area for 21 days. Period 2 will include once daily repeated topical applications on approximately 5000 cm\^2 intact occluded skin area for 21 days. Period 3 will include a single topical application on up to 400 cm\^2 gently taped-stripped skin area. Each treatment regimen will be followed by washout period for approximately 21 days, except for Treatment Period 3. Approximately 26 healthy adult subjects will be enrolled in to the study. Total duration of participation in this study will be approximately 18 weeks.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	GSK2894512 1% CREAM	It will be prepared as close as possible to the time of administration to avoid a prolonged exposure to light. Each single cream application will be made by weight, dispensed on hand (fingertips) covered with clean disposable glove and evenly spread using fingertips.
DRUG	GSK2894512 MATCHING VEHICLE CREAM	It will be prepared as close as possible to the time of administration to avoid a prolonged exposure to light. Each single cream application will be made by weight, dispensed on hand (fingertips) covered with clean disposable glove and evenly spread using fingertips.

Timeline

• Start date: 2017-12-14
• Primary completion: 2018-05-15
• Completion: 2018-05-15
• First posted: 2017-06-28
• Last updated: 2017-11-29