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The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | BMS-830216 (10 mg) |
|
| Arm 2 | Active Comparator | BMS-830216 (30 mg) |
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| Arm 3 | Active Comparator | BMS-830216 (100 mg) |
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| Arm 4 | Active Comparator | BMS-830216 (300 mg) |
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| Arm 5 | Active Comparator | BMS-830216 (600 mg) |
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| Arm 6 | Active Comparator | BMS-830216 (1200 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-830216 | Drug | Capsules, Oral, Single Dose, 1 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results | Within the 10 days after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose | Within the 10 days after study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppd Development, Lp | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Capsules, Oral, 0mg, Single Dose, 1 day |
|
| BMS-830216 | Drug | Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days |
|
| Placebo | Drug | Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |