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The purpose of this study is to evaluate the safety, tolerability and effect on body weight and other obesity-related factors of different doses of BMS-830216, compared to placebo. The study will also determine the amount of BMS-830216 in the blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel A | Active Comparator |
| |
| Panel B | Active Comparator |
| |
| Panel C | Active Comparator |
| |
| Panel D | Active Comparator |
| |
| Panel E | Active Comparator |
| |
| Panel F | Active Comparator | Low Dose |
|
| Panel G | Active Comparator | High Dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-830216 | Drug | Capsules, Oral, 30 mg, once daily, 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests | Within 2 weeks after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: to assess the multiple-dose PK of BMS-830216 | Within 2 weeks of study drug administration | |
| Pharmacodynamics: to assess the pharmacodynamic effect of BMS-830216 on body weight and BMI over 4 weeks of therapy | Within 2 weeks of 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 |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | 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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| Panel H | Placebo Comparator |
|
| BMS-830216 |
| Drug |
Capsules, Oral, 100 mg, once daily, 28 days |
|
| BMS-830216 | Drug | Capsules, oral, 300 mg, once daily, 28 days |
|
| BMS-830216 | Drug | Capsules, oral, 600 mg, once daily 28 days |
|
| BMS-830216 | Drug | Capsules, oral, 1200 mg, once daily, 28 days |
|
| BMS-830216 | Drug | Capsules, Oral, to be determined, once daily, 28 days |
|
| Placebo | Drug | Capsules, Oral, 0 mg, once daily, 28 days |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |