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The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (BMS-813160 or placebo) | Active Comparator |
| |
| Arm 2 (BMS-813160 or placebo) | Active Comparator |
| |
| Arm 3 (BMS-813160 or placebo) | Active Comparator |
| |
| Arm 4 (BMS-813160 or placebo) | Active Comparator |
| |
| Arm 5 (BMS-813160 or placebo) | Active Comparator |
| |
| Arm 6 (BMS-813160 or placebo) | Active Comparator |
| |
| Arm 7 [14C] BMS-813160 | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-813160 | Drug | Oral Solution, Oral, 5 mg, Single dose, 1 day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events | Dosing through Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of BMS-813160 | 9 times after dosing | |
| Pharmacodynamics (Plasma MCP-1) | 9 times post dose | |
| Pharmacodynamics (Circulating monocytes) |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc. | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C570874 | BMS-813160 |
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| Arm 8 (BMS-813160 or placebo) | Active Comparator |
|
| Arm 9 (BMS-813160 or placebo) | Active Comparator |
|
| BMS-813160 |
| Drug |
Oral Solution, Oral, 20 mg, Single dose, 1 day |
|
| BMS-813160 | Drug | Oral Solution, Oral, 60 mg, Single dose, 1 day |
|
| BMS-813160 | Drug | Oral Solution, Oral, 150 mg, Single dose, 1 day |
|
| BMS-813160 | Drug | Oral Solution, Oral, 300 mg, Single dose, 1 day |
|
| BMS-813160 | Drug | Oral Solution, Oral, 600 mg, Single Dose, 1 day |
|
| [14C] BMS-813160 | Drug | Oral Solution, Oral, 150 mg, Single Dose, 1 day |
|
| Placebo | Drug | Oral Solution, Oral, 0 mg, Single Dose, 1 day |
|
| BMS-813160 | Drug | Oral Solution, Oral, 1200 mg, Single dose, 1 day |
|
| BMS-813160 | Drug | Oral Solution, Oral, 2000 mg, Single Dose, 1 day |
|
| 5 times post dose |
| Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood) | 5 times post-dose |