Clinical trial NCT02089061: Drug Interaction Statin
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Coronary Syndromes
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin
timeFrame: 28 timepoints up to day 10
measure: Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin
timeFrame: 26 timepoints up to day 8
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin
timeFrame: 28 timepoints up to day 10
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin
timeFrame: 28 timepoints up to day 10
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin
timeFrame: 28 timepoints up to day 10
measure: Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin
timeFrame: 28 timepoints up to day 10
measure: Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin
timeFrame: 28 timepoints up to day 10
measure: 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
timeFrame: Up to day 10
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: