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NCT01812382 · ClinicalTrials.gov registry record · Phase 1
Retapamulin Microdialysis Feasibility Study
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01812382: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT01812382 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01812382, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This feasibility study will allow for the determination of the in vivo recovery and time of dialysis to optimize a future thorough microdialysis study. This is a single session, open label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects. Three healthy subjects will be enrolled and complete the study procedures. Subjects will be admitted to the research unit on Day 1 and three microdialysis probes will be placed in the thigh of each subject prior to the start of the microdialysis procedure. After normal saline solution infusion for 30 minutes, a Retapamulin solution will be infused for 90 minutes. Saline perfusion will occur during the washout period. Microdialysis sampling will be done for 30 minutes (during the last 30 minutes of drug perfusion) and dialysate sample collection will continue every 30 minutes for 4 hours. The approximate duration of study including follow-up is 4 days.
Primary Outcome
Retapamulin concentrations in the dialysate samples will be collected to calculate the length of time needed until disappearance of the drug in the dialysate (washout) and the percentage of drug recovered following perfusion of Retapamulin solution by microdialysis to the thigh of healthy volunteers. Microdialysis is a minimally-invasive sampling technique that is used for continuous measurement of free, unbound analyte concentrations in the extracellular fluid of virtually any tissue
Interventions
- DRUG Retapamulin Microdialysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2014-04-02 |
| Est. Completion | 2014-05-27 |
| Phase | Phase 1 |
What the finished NCT01812382 record still lists
NCT01812382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Retapamulin Microdialysis is the first listed.
NCT01812382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01812382 about?
NCT01812382 is a clinical study titled "Retapamulin Microdialysis Feasibility Study". This feasibility study will allow for the determination of the in vivo recovery and time of dialysis to optimize a future thorough microdialysis study. This is a single session, open label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects. Three healthy subjects ...
What is the current status of trial NCT01812382?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2014-04-02. Estimated completion is 2014-05-27.
What interventions are being tested in trial NCT01812382?
The interventions under investigation include: Retapamulin Microdialysis (DRUG).
Who is sponsoring clinical trial NCT01812382?
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 NCT01812382's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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