Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants
- Registration Number
- NCT04515628
- Lead Sponsor
- Bristol-Myers Squibb
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Period A: Rosuvastatin Rosuvastatin - Period D: Branebrutinib Branebrutinib - Period B: Branebrutinib Branebrutinib - Period C: Branebrutinib + Rosuvastatin and Branebrutinib Rosuvastatin - Period C: Branebrutinib + Rosuvastatin and Branebrutinib Branebrutinib -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) of rosuvastatin Up to 6 days Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib Day 13 Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib Day 13 Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin Up to 6 days Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin 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 Day 13
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 33 days Incidence of Serious Adverse Events (SAEs) Up to 77 days Incidence of AEs leading to discontinuation Up to 33 days Incidence of clinically significant changes in vital signs: Body temperature Up to 54 days Incidence of clinically significant changes in vital signs: Respiratory rate Up to 54 days Incidence of clinically significant changes in vital signs: Blood pressure Up to 54 days Incidence of clinically significant changes in vital signs: Heart rate Up to 54 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to 54 days PR interval: The time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval Up to 54 days QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval Up to 54 days QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval Up to 54 days QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 53 days Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to 53 days Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 53 days
Trial Locations
- Locations (1)
ICON (LPRA) - Salt Lake
🇺🇸Salt Lake City, Utah, United States