Acute Coronary Syndromes
Conditions
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
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin | 28 timepoints up to day 10 |
| Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin | 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 | 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 | 28 timepoints up to day 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin | 28 timepoints up to day 10 | — |
| Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin | 28 timepoints up to day 10 | — |
| Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin | 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 | Up to day 10 | Adverse Event (AE) Serious Adverse Event (SAE) |
Outcome results
None listed