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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics following single oral doses of BMS-816336 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-816336 or placebo (Panel 1) | Active Comparator |
| |
| BMS-816336 or placebo (Panel 2) | Active Comparator |
| |
| BMS-816336 or placebo (Panel 3) | Active Comparator |
| |
| BMS-816336 or placebo (Panel 4) | Active Comparator |
| |
| BMS-816336 or placebo (Panel 5) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-816336 | Drug | Suspension, Oral, 15 mg Active, Once on Day 1 only, 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exposure to the investigational drug will be measured to assess safety and tolerability | Within 72 hours following dosing |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the single dose Pharmacokinetics of BMS-816336 | During 72 hours following dosing |
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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 |
|---|---|---|---|---|---|---|
| Local Institution | Melbourne | Victoria | 3004 | Australia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000621809 | BMS-816336 |
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| BMS-816336 | Drug | Suspension, Oral, 60 mg Active, Once on Day 1 only, 4 days |
|
| BMS-816336 | Drug | Suspension, Oral, 180 mg Active, Once on Day 1 only, 4 days |
|
| BMS-816336 | Drug | Suspension, Oral, 450 mg Active, Once on Day 1 only, 4 days |
|
| BMS-816336 | Drug | Suspension, Oral, 900 mg Active, Once on Day 1 only, 4 days |
|
| Placebo | Drug | Suspension, Oral, 0 mg, Once on Day 1 only, 4 days |
|
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |