Drug Interaction Statin

Phase 1

Completed

• Conditions: Acute Coronary Syndromes
• Interventions: Drug: BMS-919373; Drug: Rosuvastatin; Drug: Atorvastatin

• Registration Number: NCT02089061
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Rosuvastatin + BMS-919373	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
Cohort 1: Rosuvastatin + BMS-919373	Rosuvastatin	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
Cohort 2: Atorvastatin + BMS-919373	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
Cohort 2: Atorvastatin + BMS-919373	Atorvastatin	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

Primary Outcome Measures

Name	Time	Method
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 extrapolated to infinite time (AUC(INF)) 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

Secondary Outcome Measures

Name	Time	Method
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
Time of maximum observed plasma concentration (Tmax) 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	Up to day 10	Adverse Event (AE); Serious Adverse Event (SAE)