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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 multiple doses of the investigational new drug, as well as the amount of study drug in the blood and its effects on blood sugar,in subjects with type 2 diabetes.
Study Classification: Safety, Pharmacokinetics/dynamics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 BMS-820132 or placebo | Active Comparator |
| |
| Arm 2 BMS-820132 or placebo | Active Comparator |
| |
| Arm 3 BMS-820132 or placebo | Active Comparator |
| |
| Arm 4 BMS-820132 or placebo | Active Comparator |
| |
| Arm 5 BMS-820132 or placebo | Active Comparator |
| |
| Arm 6 BMS-820132 or placebo | Active Comparator |
| |
| Arm 7 BMS-820132 or placebo | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | capsule, Oral, 0.0mg, twice daily, 14 day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments. | Throughout the study drug administration period (14 days) | |
| Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments. | within 7 days after the final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-820132 | Day 1 and Day 14 | |
| Time of maximum observed plasma concentration (Tmax) of BMS-820132 | Day 1 and Day 14 | |
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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 |
|---|---|---|---|---|---|---|
| Dedicated Phase I, Inc. | Phoenix | Arizona | 85013 | United States | ||
| Osborne Research Center |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Arm 8 BMS-820132 or placebo | Active Comparator |
|
| Arm 9 BMS-820132 or placebo | Active Comparator |
|
| Placebo | Drug | Capsule, Oral, 0.0mg, once daily, 14 day |
|
| BMS-820132 | Drug | Capsule, Oral, 15mg, twice daily, 14 day |
|
| BMS-820132 | Drug | Capsule, Oral, 60mg, twice daily, 14 day |
|
| BMS-820132 | Drug | Capsule, oral, 150mg, twice daily, 14 day |
|
| BMS-820132 | Drug | Capsule, Oral, 300mg, twice daily, 14 day |
|
| BMS-820132 | Drug | Capsule, Oral, 450mg, twice daily, 14 day |
|
| BMS-820132 | Drug | Capsule, Oral, To be determined (TBD), once daily, 14 day |
|
| BMS-820132 | Drug | Capsule, Oral, 5 mg, twice daily, 14 day |
|
| Trough observed plasma concentration (Cmin) of BMS-820132 |
| Day 1 through Day 14 (selected days) |
| Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132 | Day 1 and Day 14 |
| Accumulation index (AI) of BMS-820132 | Day 14 |
| Half life (T-Half) of BMS-820132 | Day 14 |
| AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis | Day -1, Day 1, Day 7 and Day 14 |
| Little Rock |
| Arkansas |
| 72201 |
| United States |
| Clinical Pharmacology Of Miami Inc. | Miami | Florida | 33014 | United States |
| Mra Clinical Research | Miami | Florida | 33143 | United States |
| Cetero Research | San Antonio | Texas | 78229 | United States |
| D004700 | Endocrine System Diseases |