Drug Interaction Statin

NCT02089061 | Completed Phase 1

• 1 other identifier: CV205-029
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

  Up to day 10

Study Arms (2)

Cohort 1: Rosuvastatin + BMS-919373

EXPERIMENTAL

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: BMS-919373; Drug: Rosuvastatin

Cohort 2: Atorvastatin + BMS-919373

EXPERIMENTAL

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: BMS-919373; Drug: Atorvastatin

Interventions

BMS-919373 DRUG

Also known as: IKur Inhibitor

Cohort 1: Rosuvastatin + BMS-919373; Cohort 2: Atorvastatin + BMS-919373

Rosuvastatin DRUG

Also known as: Crestor®

Cohort 1: Rosuvastatin + BMS-919373

Atorvastatin DRUG

Also known as: Lipitor®

Cohort 2: Atorvastatin + BMS-919373

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rosuvastatin Calcium; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08