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Drug Interaction Statin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02089061
First Posted: March 17, 2014
Last Update Posted: August 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition Intervention Phase
Acute Coronary Syndromes Drug: BMS-919373 Drug: Rosuvastatin Drug: Atorvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 28 timepoints up to day 10 ]

Secondary Outcome Measures:
  • Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin [ Time Frame: 28 timepoints up to day 10 ]
  • Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin [ Time Frame: 28 timepoints up to day 10 ]
  • Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin [ Time Frame: 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 [ Time Frame: Up to day 10 ]

    Adverse Event (AE)

    Serious Adverse Event (SAE)



Enrollment: 26
Study Start Date: March 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: BMS-919373
Other Name: IKur Inhibitor
Drug: Rosuvastatin
Other Name: Crestor®
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: BMS-919373
Other Name: IKur Inhibitor
Drug: Atorvastatin
Other Name: Lipitor®

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089061


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02089061     History of Changes
Other Study ID Numbers: CV205-029
First Submitted: March 14, 2014
First Posted: March 17, 2014
Last Update Posted: August 15, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors