Drug Interaction Statin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02089061
First received: March 14, 2014
Last updated: August 13, 2014
Last verified: August 2014
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin [ Time Frame: 28 timepoints up to day 10 ] [ Designated as safety issue: No ]
  • Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin [ Time Frame: 28 timepoints up to day 10 ] [ Designated as safety issue: No ]
  • Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin [ Time Frame: 28 timepoints up to day 10 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

    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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089061

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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02089061     History of Changes
Other Study ID Numbers: CV205-029
Study First Received: March 14, 2014
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Atorvastatin
Rosuvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014