Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
Status:
Completed
Trial end date:
2017-02-10
Target enrollment:
Participant gender:
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.