Drug Interaction Statin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-05-31

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.

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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

Conditions

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Acute Coronary Syndromes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Cohort 1: Rosuvastatin + BMS-919373

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

Group Type EXPERIMENTAL

BMS-919373

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Cohort 2: Atorvastatin + BMS-919373

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

Group Type EXPERIMENTAL

BMS-919373

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Interventions

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BMS-919373

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Atorvastatin

Intervention Type DRUG

Other Intervention Names

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IKur Inhibitor Crestor® Lipitor®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes