Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT04515628
- Run by
- Bristol-Myers Squibb
- People needed
- 22
- Starts
- 2020-08-02
- Expected to finish
- 2020-10-26
- Last updated by the study team
- 2022-03-10
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations by investigator
- Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, as measured at screening visit
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
You may not qualify if…
- Women who are of childbearing potential
- Women who are pregnant or breastfeeding
- Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study, including a history of or active liver disease
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- Other protocol-defined inclusion/exclusion criteria apply
Where it is running
- ICON (LPRA) - Salt Lake — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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