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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.
Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of Rosuvastatin and Atorvastatin in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Rosuvastatin + BMS-919373 | Experimental | 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 |
|
| Cohort 2: Atorvastatin + BMS-919373 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-919373 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Rosuvastatin | Drug |
|
|
| Atorvastatin | Drug |
|
|
| 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 | Adverse Event (AE) Serious Adverse Event (SAE) | Up to day 10 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |