Healthy Participants
Conditions
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.
Interventions
DRUGRosuvastatin
Specified dose on specified days
DRUGBranebrutinib
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | 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 to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin when coadministered with branebrutinib | Day 13 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Adverse Events (AEs) | Up to 33 days | — |
| 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 | — |
| 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 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 | — |
Countries
United States
Outcome results
None listed