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

Study Overview
=================
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.

Official Title
-----------------
An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State Branebrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Branebrutinib


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period A: Rosuvastatin<br> | Drug: Rosuvastatin<br>* Specified dose on specified days<br>|
| Experimental: Period B: Branebrutinib<br> | Drug: Branebrutinib<br>* Specified dose on specified days<br>|
| Experimental: Period C: Branebrutinib + Rosuvastatin and Branebrutinib<br> | Drug: Rosuvastatin<br>* Specified dose on specified days<br>Drug: Branebrutinib<br>* Specified dose on specified days<br>|
| Experimental: Period D: Branebrutinib<br> | Drug: Branebrutinib<br>* Specified dose on specified days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 54 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the QRS complex represents ventricular depolarization | Up to 54 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 54 days | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to 54 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 |