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The purpose of this study is to determine the safety and tolerability of BMS-820836 after single doses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-820836 (Part 1, Panel 1) | Active Comparator |
| |
| BMS-820836 (Part 1, Panel 2) | Active Comparator |
| |
| BMS-820836 (Part 1, Panel 3) | Active Comparator |
| |
| BMS-820836 (Part 1, Panel 4) | Active Comparator |
| |
| BMS-820836 (Part 1, Panel 5) | Active Comparator |
| |
| BMS-820836 (Part 1, Panel 6) | Active Comparator |
| |
| BMS-820836 (Part 1, Panel 7) | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-820836 | Drug | Oral Solution, Oral, 0.025 mg, single dose, one dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of BMS-820836 following single-dose administration | Within 14 days of first dose |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007 | Within 7 days of dosing | |
| To assess the pharmacodynamics of BMS-820836 | Within 48 hours of 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 | Toronto | Ontario | M5V 2T3 | Canada |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000594001 | 6-(2-methyl-4-(2-naphthyl)-1,2,3,4-tetrahydroisoquinolin-7-yl)pyridazin-3-amine |
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| BMS-820836 (Part 1, Panel 8) | Active Comparator |
|
| BMS-820836 (Part 1, Panel 9) | Active Comparator |
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| BMS-820836 (Part 2, Panel A) | Active Comparator |
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| BMS-820836 (Part 2, Panel B) | Active Comparator |
|
| BMS-820836 |
| Drug |
Oral Solution, Oral, 0.1 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 0.25 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 0.5 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 1 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 2 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 3 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 5 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 8 mg, single dose, one dose |
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| Placebo | Drug | Oral Solution, Oral, 0 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 3 mg, single dose, one dose |
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| BMS-820836 | Drug | Oral Solution, Oral, 0.5 mg, single dose, one dose |
|