A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin

Study Overview
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Brief Summary
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Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants

Official Title
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An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: rosuvastatin
* Drug: BMS-963272


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Women must not be of childbearing potential (WNOCBP) Women and men must agree to follow instructions for methods of contraception Exclusion Criteria: Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study. Any major surgery within 4 weeks of study drug administration Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration Previous treatment with BMS-963272 Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1 Other protocol-defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rosuvastatin + BMS-963272<br> | Drug: rosuvastatin<br>* Specified dose on specified days<br>Drug: BMS-963272<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | up to Day 10 | 
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T) |  | up to Day 10 | 
| Area under the plasma concentration-time curve extrapolated to infinity AUC (INF) |  | up to Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Approximately 50 days | 
| Number of significant changes in lab assessments of blood serum |  | Approximately 50 days | 
| Number of significant changes in lab assessments of blood |  | Approximately 50 days | 
| Number of significant changes in lab assessments of urine |  | Approximately 50 days | 
| Blood pressure |  | Approximately 50 days | 
| Body temperature |  | Approximately 50 days | 
| Respiratory rate |  | Approximately 50 days | 
| Number of Participants with abnormal physical examination findings |  | Approximately 50 days | 
| Heart rate |  | Approximately 50 days | 
| Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities |  | Approximately 50 days |