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NCT01459315 · ClinicalTrials.gov registry record · Phase 1
GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT01459315: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01459315 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01459315, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid, rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of an investigational HIV medication known as GSK1349572 (dolutegravir).
Primary Outcome
The area under the concentration time curve will be determined from all sample collection time points over a 24 hour period. Sample collection for blood plasma will occur pre-dose, then 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours post-dose. AUCs will be determined for individual subjects and for all subjects combined following a single dose.
Interventions
- DRUG dolutegravir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 1 |
What the finished NCT01459315 record still lists
NCT01459315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which dolutegravir is the first listed.
NCT01459315 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01459315 about?
NCT01459315 is a clinical study titled "GSK1349572 Exposure in Blood, Seminal Fluid, and Rectal Fluid and Tissue in Healthy Male Subjects". The purpose of this study is to describe drug concentrations in blood plasma, rectal fluid, rectal tissue, and seminal fluid in HIV negative men following single and multiple doses of an investigational HIV medication known as GSK1349572 (dolutegravir).
What is the current status of trial NCT01459315?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2011-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01459315?
The interventions under investigation include: dolutegravir (DRUG).
Who is sponsoring clinical trial NCT01459315?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01459315's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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