Drug Interaction Statin

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Acute Coronary Syndromes

Treatments: Drug: Atorvastatin; Drug: BMS-919373; Drug: Rosuvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02089061

CV205-029

Details and patient eligibility

About

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.

Full description

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

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

26 participants in 2 patient groups

Cohort 1: Rosuvastatin + BMS-919373

Experimental group

Description:

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

Treatment:

Drug: Rosuvastatin

Drug: BMS-919373

Cohort 2: Atorvastatin + BMS-919373

Experimental group

Description:

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

Treatment:

Drug: BMS-919373

Drug: Atorvastatin