Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
Completed · Phase 1 · Has a placebo group
Conditions studied: Wound Healing
In brief
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.
Key facts
- Study ID
- NCT01831804
- Run by
- GlaxoSmithKline
- People needed
- 65
- Starts
- 2013-06-17
- Expected to finish
- 2017-02-10
- Last updated by the study team
- 2019-08-19
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
Where it is running
- GSK Investigational Site — Castro Valley, California, United States
- GSK Investigational Site — Washington D.C., District of Columbia, United States
- GSK Investigational Site — Miami, Florida, United States
- GSK Investigational Site — Pinellas Park, Florida, United States
- GSK Investigational Site — Las Vegas, Nevada, United States
- GSK Investigational Site — Providence, Rhode Island, United States
- GSK Investigational Site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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