NCT01831804

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863

Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Topical GSK1278863 in Healthy Volunteers and Diabetic Patients, and Repeat Doses of GSK1278863 in Diabetic Patients for the Treatment of Diabetic Foot Ulcer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo-controlled, single-blind (subjects and investigators will be blinded, GSK internal personnel will not be blinded), parallel-group, two part (Part A, Part B) trial in healthy volunteers and subjects with diabetic foot ulcers. Part A is designed to evaluate single applications of GSK1278863 in one cohort of healthy volunteers (intact skin) and approximately 3 cohorts of diabetic subjects. Part B is designed to evaluate first single, and then repeat applications of GSK1278863 in diabetics, both in the clinic and by subjects at home. Part B will include approximately 3 cohorts in which the concentration of drug applied will be determined by pharmacokinetic data from Part A and earlier cohorts in Part B.

Conditions

• Wound Healing

Interventions

Type	Name	Description
DRUG	GSK1278863	White to off-white smooth ointment with unit dose strength of 0.05%w/w, 0.1%w/w, 0.5%w/w, 1.0%w/w for topical application as single or repeat doses.
DRUG	Placebo	White to off-white smooth ointment for topical application as single or repeat doses.

Timeline

• Start date: 2013-06-17
• Primary completion: 2017-02-10
• Completion: 2017-02-10
• First posted: 2013-04-15
• Last updated: 2019-08-19
• Results posted: 2019-08-19

Locations

7 sites across 1 country: United States