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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: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01831804 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events; or is associated with liv
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 |
What the finished NCT01831804 record still lists
NCT01831804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01831804 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01831804's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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