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

Bristol-Myers Squibb22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

RosuvastatinDRUG

Specified dose on specified days

BranebrutinibDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ICON (LPRA) - Salt Lake

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax) of rosuvastatin

Time frame: Up to 6 days

Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib

Time frame: Day 13

Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin

Time frame: Up to 6 days

Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib

Time frame: Day 13

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin

Time frame: Up to 6 days

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin when coadministered with branebrutinib

Time frame: Day 13

Secondary Outcomes

Incidence of Adverse Events (AEs)

Time frame: Up to 33 days

Incidence of Serious Adverse Events (SAEs)

Time frame: Up to 77 days

Incidence of AEs leading to discontinuation

Time frame: Up to 33 days

Incidence of clinically significant changes in vital signs: Body temperature

Time frame: Up to 54 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.