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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018461-38 | EudraCT Number |
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The main purpose of this study is to determine whether multiple doses.of BMS-886949 are safe and tolerable
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo or BMS-866949 (3 mg) | Active Comparator | Panel 1: Healthy Male Subjects |
|
| Placebo or BMS-866949 (10 mg) | Active Comparator | Panel 2: Healthy Male Subjects |
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| Placebo or BMS-866949 (30 mg) | Active Comparator | Panel 3: Healthy Male Subjects |
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| Placebo or BMS-866949 (45 mg) | Active Comparator | Panel 4: Healthy Male Subjects |
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| Placebo or BMS-866949 (60 mg) | Active Comparator | Panel 5: Healthy Male Subjects |
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| Placebo or BMS-866949 (90 mg) | Active Comparator | Panel 6: Healthy Male Subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral Solution, Oral, 0 mg, Once Daily, 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety by evaluating incidence of adverse events (AE) | Over a period of 28 days (+/- 2 days) of first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacokinetics by evaluating plasma concentration versus time data | Over a period 28 days (+/- 2 days) of first dose | |
| Assessment of pharmacodynamics by evaluating brain transporter occupancy | Over a period 28 days (+/- 2 days) of first dose |
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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 | Uppsala | 751 23 | Sweden |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Placebo or BMS-866949 (3 - 60 mg) | Active Comparator | Panel 7: Females |
|
| BMS-866949 | Drug | Oral Solution, Oral, 3 mg, Once Daily, 14 days |
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| BMS-866949 | Drug | Oral Solution, Oral, 10 mg, Once Daily, 14 days |
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| BMS-866949 | Drug | Oral Solution, Oral, 30 mg, Once Daily, 14 days |
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| BMS-866949 | Drug | Oral Solution, Oral, 45 mg, Once Daily, 14 days |
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| BMS-866949 | Drug | Oral Solution, Oral, 60 mg, Once Daily, 14 days |
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| BMS-866949 | Drug | Oral Solution, Oral, 90 mg, Once Daily, 14 days |
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| BMS-866949 | Drug | Oral Solution, Oral, 3-60 mg, Once Daily, 14 days |
|