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Completed

NCT Number: NCT02089061

Drug Interaction Statin

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.

Completed

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-919373

Drug

Other names: IKur Inhibitor

Rosuvastatin

Drug

Other names: Crestor®

atorvastatin

Drug

Other names: Lipitor®

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin

    Time frame: 28 timepoints up to day 10

  2. Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin

    Time frame: 26 timepoints up to day 8

  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin

    Time frame: 28 timepoints up to day 10

  4. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin

    Time frame: 28 timepoints up to day 10

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin

    Time frame: 28 timepoints up to day 10

  2. Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin

    Time frame: 28 timepoints up to day 10

  3. Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin

    Time frame: 28 timepoints up to day 10

  4. 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

    Time frame: Up to day 10

    Adverse Event (AE)

    Serious Adverse Event (SAE)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2014
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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