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The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 (BMS-708163) | Active Comparator |
| |
| A2 (Placebo) | Placebo Comparator |
| |
| B1 (BMS-708163) | Active Comparator |
| |
| B2 (Placebo) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-708163 | Drug | Capsule, Oral, 50 mg, once daily, 1 Day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance | Study Day 1 through study completion + 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data | Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2 |
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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 |
|---|---|---|---|---|---|---|
| West Coast Clinical Trials, Llc | Cypress | California | 90630 | United States | ||
| California Clinical Trials Medical Group |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C554092 | BMS 708163 |
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| BMS-708163 |
| Drug |
Capsule, Oral, 125 mg, once daily, 14 Days |
|
| Placebo | Drug | Capsule, Oral, 0 mg, One daily, 1 Day |
|
| Placebo | Drug | Capsule, Oral, 0 mg, One daily, 14 Day |
|
| Glendale |
| California |
| 91206 |
| United States |
| Iberica Clinical Research Center | Eatontown | New Jersey | 07724 | United States |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |