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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT # is 2009-010220-26 |
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The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-866949 (Panel 1) | Experimental |
| |
| BMS-866949 (Panel 2) | Experimental |
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| BMS-866949 (Panel 3) | Experimental |
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| BMS-866949 (Panel 4) | Experimental |
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| BMS-866949 (Panel 5) | Experimental |
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| BMS-866949 (Panel 6) | Experimental |
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| BMS-866949 (Panel 7) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-866949 | Drug | (Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs | up to Day 14 +/- 2 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples | Blood samples will be taken up to 144 hour post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Uppsala | 751 23 | Sweden |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| BMS-866949 |
| Drug |
(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days |
|
| BMS-866949 | Drug | (Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days |
|
| BMS-866949 | Drug | (Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days |
|
| BMS-866949 | Drug | (Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days |
|
| BMS-866949 | Drug | (Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days |
|
| BMS-866949 | Drug | (Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days |
|
| Placebo | Drug | (Matching volume) - Oral Solution, Oral, once 14 days |
|