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NCT02411162 · ClinicalTrials.gov registry record · Phase 1
A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream
A Phase 1 study, sponsored by Stiefel, a GSK Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02411162: Completed Phase 1 study, sponsored by Stiefel, a GSK Company.
NCT02411162 is a Phase 1 study that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02411162, a Phase 1 study, has completed, sponsored by Stiefel, a GSK Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will assess the residence time in human skin . The primary objective is to evaluate the residency time in skin following topical application of two formulations of GSK2894512 Cream. The total study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of post treatment period and 1 day of follow up. The screening period will be up to 28 days prior to Baseline (Day 1).
Primary Outcome
Fluorescent lifetime imaging microscopy (FLIM) images will be evaluated to determine if GSK2894512 is detectable in skin. Drug concentrations can be quantified considering the: depth of penetration at each time point and the amount of fluorescence detected. Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) will also be used to measure the concentration of GSK2894512 from biopsies.
Interventions
- DRUG Combination therapy GSK2894512 Cream A + GSK2894512 Cream B
- DRUG Combination therapy Vehicle Cream A + Vehicle Cream B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2015-07-07 |
| Est. Completion | 2015-09-24 |
| Phase | Phase 1 |
What the finished NCT02411162 record still lists
NCT02411162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Combination therapy GSK2894512 Cream A + GSK2894512 Cream B is the first listed.
NCT02411162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02411162 about?
NCT02411162 is a clinical study titled "A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream". This will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will assess the residence time in...
What is the current status of trial NCT02411162?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2015-07-07. Estimated completion is 2015-09-24.
What interventions are being tested in trial NCT02411162?
The interventions under investigation include: Combination therapy GSK2894512 Cream A + GSK2894512 Cream B (DRUG), Combination therapy Vehicle Cream A + Vehicle Cream B (DRUG).
Who is sponsoring clinical trial NCT02411162?
This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02411162's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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