Drug Interaction Statin

Study Overview
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Brief Summary
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This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.

Detailed Description
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Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of Rosuvastatin and Atorvastatin in healthy subjects

Official Title
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A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects

Conditions
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Acute Coronary Syndromes

Intervention / Treatment
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* Drug: BMS-919373
* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Signed Written Informed Consent form Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive Men and women, ages 18 to 55 yrs, inclusive Exclusion Criteria: Current or history of cardiovascular diseases, including arrhythmias, coronary heart disease, and congestive heart failure Current or history of symptomatic hypotension Current or history of liver diseases, including cirrhosis and liver failure Current or history of kidney diseases, including nephrotic syndrome, renal failure, nephrolithiasis, and urolithiasis Current or history of neurological diseases, including presyncope, syncope, convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders Exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator History of significant head injury in the last 2 years

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

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Rosuvastatin + BMS-919373<br>Rosuvastatin 10 mg tablet orally once for Day 1 and 5 BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension | Drug: BMS-919373<br> <br> * Other names: IKur Inhibitor;Drug: Rosuvastatin<br> <br> * Other names: Crestor®;|
| Experimental: Cohort 2: Atorvastatin + BMS-919373<br>Atorvastatin 40 mg tablet once for Days 1 and 5 BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension | Drug: BMS-919373<br> <br> * Other names: IKur Inhibitor;Drug: Atorvastatin<br> <br> * Other names: Lipitor®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin |  | 28 timepoints up to day 10 | 
| Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin |  | 26 timepoints up to day 8 | 
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin |  | 28 timepoints up to day 10 | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin |  | 28 timepoints up to day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin |  | 28 timepoints up to day 10 | 
| Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin |  | 28 timepoints up to day 10 | 
| Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin |  | 28 timepoints up to day 10 | 
| Safety based on results of physical examinations, vital sign measurements, ECGs, 24-hour telemetry, clinical laboratory tests, and physical measurements and will also include the incidence of AEs, SAEs and AEs leading to discontinuation | Adverse Event (AE) Serious Adverse Event (SAE) | Up to day 10 |