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Drug Interaction Statin

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ClinicalTrials.gov Identifier: NCT02089061
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Drug: BMS-919373 Drug: Rosuvastatin Drug: Atorvastatin Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
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
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Arms and Interventions
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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: 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®


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)



Eligibility Criteria
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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
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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
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02089061    
Other Study ID Numbers: CV205-029
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Rosuvastatin Calcium
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors