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NCT01332565 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT01332565: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT01332565 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01332565, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is a Phase 1, open label, non-randomized, single dose study to determine pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be enrolled in this study to receive a 50 mg single dose of DTG. Subjects will have a screening visit within 30 days prior to the administration of study drug, a treatment visit, and a follow-up visit 7-14 days after the administration of study drug.
Interventions
- DRUG GSK1349572
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-04 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT01332565 record still lists
NCT01332565 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK1349572 is the first listed.
NCT01332565 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01332565 about?
NCT01332565 is a clinical study titled "A Study to Investigate the Pharmacokinetics, Safety and Tolerability of GSK1349572 (Dolutegravir, DTG) in Healthy Japanese Subjects". This study is a Phase 1, open label, non-randomized, single dose study to determine pharmacokinetics, safety and tolerability of doultegravir (DTG) following 50 mg single oral administration in healthy Japanese subjects. A total of 10 healthy Japanese subjects will be enrolled in this study to recei...
What is the current status of trial NCT01332565?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2011-04. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01332565?
The interventions under investigation include: GSK1349572 (DRUG).
Who is sponsoring clinical trial NCT01332565?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01332565's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 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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