Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Branebrutinib; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04515628

IM014-032

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 4 patient groups

Period A: Rosuvastatin

Experimental group

Treatment:

Drug: Rosuvastatin

Period B: Branebrutinib

Experimental group

Treatment:

Drug: Branebrutinib

Period C: Branebrutinib + Rosuvastatin and Branebrutinib

Experimental group

Treatment:

Drug: Rosuvastatin

Drug: Branebrutinib

Period D: Branebrutinib

Experimental group

Treatment:

Drug: Branebrutinib