NCT02466152

Pharmacokinetic Study of Topical GSK2894512 Cream

A Pharmacokinetic Study for Systemic Exposure of Twice Daily Topically Applied GSK2894512 Cream in Subjects With Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the systemic exposure and pharmacokinetic parameters of GSK2894512 following twice daily topical administration of 1% and 2% cream in adult subjects with AD, and will provide information about the systemic safety as well as local safety and tolerability following twice daily application to up to 35% body surface area (BSA) of affected skin of subjects with AD. It will be an open-label, sequential study consisting of 2 cohorts. A cohort of 6 subjects (Cohort 1) will apply GSK2894512 (cream, 2%) to affected skin on an area ranging from 15 to 35% of the total BSA for 20 days plus a final dose on Day 21. Cohort 2 will consist of 6 subjects that will apply 1% cream. Cohort 2 will follow the same procedures as Cohort 1.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	GSK2894512 Topical Cream	GSK2894512 will be supplied as white to off-white topical cream in doses of 2.0% (20 milligrams/gram \[mg/g\]) and 1.0% (10 mg/g)

Timeline

• Start date: 2015-05-28
• Primary completion: 2015-10-27
• Completion: 2015-10-27
• First posted: 2015-06-09
• Last updated: 2017-05-09

Locations

1 site across 1 country: Canada