Drug Interaction Statin

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Atorvastatin; Atorvastatin Calcium; Rosuvastatin Calcium

Criteria

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