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NCT03836729 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03836729 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 16 participants.
The verdict
NCT03836729, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Human immunodeficiency virus (HIV) infection frequently involves combination drug therapy for its treatment; hence, it is important to understand their interactions and resulting changes in exposure which are associated with medications. This is a Phase-1, open-label, fixed-sequence 2-period, one-way drug interaction study to assess the pharmacokinetic (PK), safety, and tolerability of GSK3640254 and Tenofovir alafenamide/emtricitabine (TAF/FTC) when administered alone and in combination in healthy subjects. The study will consist of a screening period of 28 days before the first dose of study intervention followed by 2 sequential treatment periods. Subjects will be administered TAF/FTC 25/200 milligram (mg) once daily (QD) on Days 1 to 14 of Period 1 followed by co-administration of TAF/FTC 25/200 mg QD with GSK3640254 200 mg QD on Days 1 to 7 of Period 2.
Interventions
- DRUG GSK3640254
- DRUG Tenofovir alafenamide/emtricitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-02-11 |
| Est. Completion | 2019-04-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03836729
The ClinicalTrials.gov registry entry for NCT03836729 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 2 interventions - of which GSK3640254 is the first listed.
NCT03836729 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03836729 about?
NCT03836729 is a clinical study titled "Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine". Human immunodeficiency virus (HIV) infection frequently involves combination drug therapy for its treatment; hence, it is important to understand their interactions and resulting changes in exposure which are associated with medications. This is a Phase-1, open-label, fixed-sequence 2-period, one-wa...
What is the current status of trial NCT03836729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-02-11. Estimated completion is 2019-04-30.
What interventions are being tested in trial NCT03836729?
The interventions under investigation include: GSK3640254 (DRUG), Tenofovir alafenamide/emtricitabine (DRUG).
Who is sponsoring clinical trial NCT03836729?
This trial is sponsored by ViiV Healthcare, which has 182 total clinical trials registered on ClinicalTrials.gov.
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