Drug Interaction Statin

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndromes
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Atorvastatin; Drug: BMS-919373

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Rosuvastatin; Other Names: Crestor®; Drug: BMS-919373; Other Names: IKur Inhibitor
Experimental: 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	Drug: Atorvastatin; Other Names: Lipitor®; Drug: BMS-919373; Other Names: IKur Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: CV205-029