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The purpose of this study is to evaluate the safety, tolerability and effect on blood glucose control of BMS-903452 compared to placebo in healthy subjects & relative bioavailability of the crystalline and amorphous forms of BMS-903452 [Panels 4,6,11 & 12(Part A)] ; and subjects with type 2 Diabetes Mellitus (Part B). The study will also determine the amount of BMS-903452 in the blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-903452 (0.1 mg) or Placebo - A1 | Experimental | (Healthy Subjects) |
|
| BMS-903452 (0.6 mg) or Placebo - A2 | Experimental | (Healthy Subjects) |
|
| BMS-903452 (3.0 mg) or Placebo - A3 | Experimental | (Healthy Subjects) |
|
| BMS-903452 (10 mg) or Placebo - A4 | Experimental | (Healthy Subjects) |
|
| BMS-903452 (30 mg) or Placebo - A5 | Experimental | (Healthy Subjects) |
|
| BMS-903452 (60 mg) or Placebo - A6 | Experimental | (Healthy Subjects) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-903452 | Drug | Solution, Oral, 0.1 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 10 days of study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism | Within 2 days of study drug administration | |
| Effect on electrocardiographic (ECG) parameters | Within 10 days 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 |
|---|---|---|---|---|---|---|
| Comprehensive Phase One | Miramar | Florida | 33025 | United States | ||
| Ppd Development, Lp |
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|
| BMS-903452 (120 mg) or Placebo - A7 | Experimental | (Healthy Subjects) |
|
| BMS-903452 (0.6 mg) or Placebo - B1 | Experimental | (Subjects with type 2 Diabetes Mellitus) |
|
| BMS-903452 (10 mg) or Placebo - B2 | Experimental | (Subjects with type 2 Diabetes Mellitus) |
|
| BMS-903452 (120 mg) or Placebo - B3 | Experimental | (Subjects with type 2 Diabetes Mellitus) |
|
| BMS-903452 (10 mg) or Placebo - A11 | Experimental | (Healthy Subjects) |
|
| BMS-903452 (60 mg) or Placebo - A12 | Experimental | (Healthy Subjects) |
|
| BMS-903452 |
| Drug |
Solution, Oral, 0.6 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension, Oral, 3.0 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension, Oral, 10 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension, Oral, 30 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension, Oral, 60 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension, Oral, 120 mg, once daily, 1 day |
|
| Placebo | Drug | Solution, Oral, 0 mg, once daily, 1 day |
|
| Placebo | Drug | Suspension, Oral, 0 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension using crystalline form, Oral, 10 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension using crystalline form, Oral, 60 mg, once daily, 1 day |
|
| Placebo | Drug | Suspension using crystalline form, Oral, 0 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Solution, Oral, 0.6 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension, Oral, 10 mg, once daily, 1 day |
|
| BMS-903452 | Drug | Suspension, Oral, 120 mg, once daily, 1 day |
|
| Percent urinary recovery (% UR) | derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses | Within 10 days of study drug administration |
| Renal clearance (CLR) from plasma | derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses | Within 10 days of study drug administration |
| The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration |
| The single-dose pharmacokinetics parameter time to reach maximum observed concentration in plasma (Tmax) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration |
| The single-dose pharmacokinetics parameter time Area under the plasma concentration-time curve from time zero extrapolated to infinity AUC(INF) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration |
| The single-dose pharmacokinetics parameter Area under the plasma concentration-time curve from time zero to last measurable sampling time AUC (0-T) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration |
| The single-dose pharmacokinetics parameter Terminal-phase elimination half-life in plasma (T-Half) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration |
| The single-dose pharmacokinetics parameter apparent clearance from plasma after extra-vascular administration (CLT/F) of BMS-903452 will be derived from the plasma concentration versus time data | Within 10 days after study drug administration |
| Austin |
| Texas |
| 78744 |
| United States |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000593257 | 5-chloro-4-((1-(5-chloropyrimidin-2-yl)piperidin-4-yl)oxy)-1-(2-fluoro-4-(methylsulfonyl)phenyl)pyridin-2(1H)-one |
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