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NCT01831804 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT01831804 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 65 participants.
The verdict
NCT01831804, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG GSK1278863
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2013-06-17 |
| Est. Completion | 2017-02-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01831804
The ClinicalTrials.gov registry entry for NCT01831804 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01831804 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01831804 about?
NCT01831804 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single and Repeated Doses of Topical GSK1278863". 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 applica...
What is the current status of trial NCT01831804?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2013-06-17. Estimated completion is 2017-02-10.
What interventions are being tested in trial NCT01831804?
The interventions under investigation include: Placebo (DRUG), GSK1278863 (DRUG).
Who is sponsoring clinical trial NCT01831804?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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