Trials / Completed
CompletedNCT04630002
Drug-drug Interaction (DDI) Study of GSK3640254 With Darunavir/Ritonavir (DRV/RTV) and Etravirine (ETR)
Open-Label, Single-Sequence Study to Evaluate the Effects of Darunavir/Ritonavir and/or Etravirine on the Pharmacokinetics of GSK3640254 and the Effects of GSK3640254 on the Pharmacokinetics of Darunavir/Ritonavir and/or Etravirine in Heathy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- ViiV Healthcare · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GSK3640254 | GSK3640254 will be available as oral tablets. |
| DRUG | Darunavir/Ritonavir (DRV/RTV) | DRV/RTV will be available as oral tablets. |
| DRUG | Etravirine (ETR) | ETR will be available as oral tablets. |
Timeline
- Start date
- 2020-10-28
- Primary completion
- 2021-10-02
- Completion
- 2021-10-02
- First posted
- 2020-11-16
- Last updated
- 2024-08-29
- Results posted
- 2023-08-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04630002. Inclusion in this directory is not an endorsement.