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The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-820836 in healthy Japanese subjects and Japanese patients with depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1: BMS-820836 | Experimental | Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg) |
|
| Arm 2: Placebo matching BMS-820836 | Placebo Comparator | Panels 1-4 are fixed dose panels (0.5, 1, 1 and 2 mg respectively), Panels 5-7 are titration dose panels (initiated at 1 mg and dose escalated to the target dose of 2 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-820836 | Drug | Tablets, Oral, 0.5 mg, Once daily, 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability based on medical review of adverse events & results of vital sign measurements, electrocardiogram (ECGs), physical examinations, clinical laboratory test, suicidality evaluation & Montgomery Asberg Depression Rating Scale (MADRS) | Day 1 through Day 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple-dose pharmacokinetics parameter Maximum observed concentration (Cmax) of BMS-820836 and BMS-821007 | Day1 through Day 33 | |
| Multiple-dose pharmacokinetics parameter Concentration at 24 h (C24) of BMS-820836 and BMS-821007 | Day1 through Day 33 |
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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 | Taito-Ku | Tokyo | 1110052 | Japan |
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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 |
| Drug |
Tablets, Oral, 1 mg, Once daily, 14 days |
|
| BMS-820836 | Drug | Tablets, Oral, 2 mg, Once daily, 14 days |
|
| Placebo matching BMS-820836 | Drug | Tablets, Oral, 0 mg, Once daily, 14 days |
|
| BMS-820836 | Drug | Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days |
|
| Multiple-dose pharmacokinetics parameter Time of maximum observed concentration (Tmax) of BMS-820836 and BMS-821007 | Day1 through Day 33 |
| Multiple-dose pharmacokinetics parameter Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-820836 and BMS-821007 | Day1 through Day 33 |
| Multiple-dose pharmacokinetics parameter Apparent total body clearance (CLT/F) of BMS-820836 and BMS-821007 | Day1 through Day 33 |
| Multiple-dose pharmacokinetics parameter accumulation index (AI) of BMS-820836 and BMS-821007 | Day1 through Day 33 |
| Multiple-dose pharmacokinetics parameter half-life (T-HALF) of BMS-820836 and BMS-821007 | Day1 through Day 33 |
| Multiple-dose pharmacokinetics parameter Molar ratio of metabolite to parent Cmax or AUC(TAU) | Day1 through Day 33 |
| ECG parameters (heart rate, PR, QRS, QT, and QTcF intervals) | QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula | Day1 through Day 33 |
| Vital sign measures (heart rate and blood pressure) and the orthostatic changes | Day1 through Day 33 |