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NCT04630002 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
A Phase 1 study, sponsored by ViiV Healthcare.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT04630002: Completed Phase 1 study, sponsored by ViiV Healthcare.
NCT04630002 is a Phase 1 study that has completed, run by ViiV Healthcare. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04630002, a Phase 1 study, has completed, sponsored by ViiV Healthcare.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is an open-label, single-sequence, multiple-dose, 3 cohort study to investigate the effects of DRV/RTV and/or ETR on the pharmacokinetics (PK) of GSK3640254 and the effects of GSK3640254 on the PK of DRV/RTV and/or ETR. This study will aid in understanding these interactions and resulting changes in exposure (if any) when given in combination with GSK3640254.
Primary Outcome
Blood samples were collected at indicated time points. Pharmacokinetic analysis was conducted using standard non-compartmental methods.
Interventions
- DRUG GSK3640254
- DRUG Etravirine (ETR)
- DRUG Darunavir/Ritonavir (DRV/RTV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-10-28 |
| Est. Completion | 2021-10-02 |
| Phase | Phase 1 |
What the finished NCT04630002 record still lists
NCT04630002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which GSK3640254 is the first listed.
NCT04630002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04630002 about?
NCT04630002 is a clinical study titled "Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)". This is an open-label, single-sequence, multiple-dose, 3 cohort study to investigate the effects of DRV/RTV and/or ETR on the pharmacokinetics (PK) of GSK3640254 and the effects of GSK3640254 on the PK of DRV/RTV and/or ETR. This study will aid in understanding these interactions and resulting chang...
What is the current status of trial NCT04630002?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2020-10-28. Estimated completion is 2021-10-02.
What interventions are being tested in trial NCT04630002?
The interventions under investigation include: GSK3640254 (DRUG), Etravirine (ETR) (DRUG), Darunavir/Ritonavir (DRV/RTV) (DRUG).
Who is sponsoring clinical trial NCT04630002?
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 NCT04630002's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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