Trials / Completed
CompletedNCT04515628
Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants
An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State Branebrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents, rosuvastatin is also a likely concomitant drug for participants who would potentially be treated with branebrutinib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rosuvastatin | Specified dose on specified days |
| DRUG | Branebrutinib | Specified dose on specified days |
Timeline
- Start date
- 2020-08-02
- Primary completion
- 2020-10-18
- Completion
- 2020-10-26
- First posted
- 2020-08-17
- Last updated
- 2022-03-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04515628. Inclusion in this directory is not an endorsement.