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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 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 10 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01332565
The ClinicalTrials.gov registry entry for NCT01332565 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ViiV Healthcare, which has 182 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GSK1349572 is the first listed.
NCT01332565 reports 0 study locations.
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.
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