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NCT01467531 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01467531 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 28 participants.
The verdict
NCT01467531, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
Interventions
- DRUG Dolutegravir
- DRUG GSK1265744
- DRUG Rlipivirine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-11 |
| Est. Completion | 2012-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01467531
The ClinicalTrials.gov registry entry for NCT01467531 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 3 interventions - of which Dolutegravir is the first listed.
NCT01467531 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01467531 about?
NCT01467531 is a clinical study titled "A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects". This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects...
What is the current status of trial NCT01467531?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-11. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01467531?
The interventions under investigation include: Dolutegravir (DRUG), GSK1265744 (DRUG), Rlipivirine (DRUG).
Who is sponsoring clinical trial NCT01467531?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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