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BMS-820132 is an investigational new drug being developed by BMS for treating Type 2 diabetes. The purpose of this study is to test the safety/tolerability (potential side effects) of single doses of the investigational new drug, as well as the amount of study drug in the blood, in subjects with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-820132 (0.3 mg) or Placebo | Active Comparator |
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| BMS-820132 (1.0 mg) or Placebo | Active Comparator |
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| BMS-820132 (3 mg) or Placebo | Active Comparator |
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| BMS-820132 (10 mg) or Placebo | Active Comparator |
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| BMS-820132 (30 mg) or Placebo | Active Comparator |
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| BMS-820132 (75 mg) or Placebo | Active Comparator |
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| BMS-820132 (150 mg) or Placebo | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-820132 | Drug | Oral Solution, Oral, 0.3 mg, once daily, 1 day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments | Within 5 days of study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to the investigational drug and its metabolites | Within 2 days after study drug administration | |
| Pharmacodynamic activity of the investigational drug on biomarkers | Within 2 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 |
|---|---|---|---|---|---|---|
| Profil Institute For Clinical Research, Inc. (Picr) | Chula Vista | California | 91911 | United States | ||
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| BMS-820132 (300 mg) or Placebo | Active Comparator |
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| BMS-820132 (TBD) or Placebo | Active Comparator |
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| BMS-820132 |
| Drug |
Oral Solution, Oral, 1.0 mg, once daily, 1 day |
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| BMS-820132 | Drug | Oral Solution, Oral, 3 mg, once daily, 1 day |
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| BMS-820132 | Drug | Oral Solution, Oral, 10 mg, once daily, 1 day |
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| BMS-820132 | Drug | Oral Solution, Oral, 30 mg, once daily, 1 day |
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| BMS-820132 | Drug | Oral Solution, Oral , 75 mg, once daily, 1 day |
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| BMS-820132 | Drug | Oral Solution, Oral, 150 mg, once daily, 1 day |
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| BMS-820132 | Drug | Oral Solution, Oral, 300 mg, once daily, 1 day |
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| BMS-820132 | Drug | Capsule, Oral, (TBD), once daily, 2 days |
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| Placebo | Drug | Oral Solution, Oral, 0mg, once daily, 1 day |
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| Placebo | Drug | Capsule, Oral, (TBD), once daily, 2 days |
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| Excretion of the investigational drug and metabolites from the body | Within 2 days after study drug administration |
| Clinical Pharmacology Of Miami Inc. |
| Miami |
| Florida |
| 33014 |
| United States |
| Elite Research Institute | Miami | Florida | 33169 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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