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The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (Reference) | Experimental |
| |
| Treatment B | Active Comparator |
| |
| Treatment C | Active Comparator |
| |
| Treatment D | Active Comparator |
| |
| Treatment E | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-708163 | Drug | Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the bioavailability of 4 experimental formulations relative to the current reference formulation | Day 1, up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Adverse Events | Day 1, up to 3 weeks | |
| Safety: Vital Signs | Screening, Day 1 and Day 4 of each period | |
| Safety: ECGs |
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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 |
|---|---|---|---|---|---|---|
| Mds Pharma Services (Us) Inc. | Neptune City | New Jersey | 07753 | United States |
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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 | Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings |
|
| BMS-708163 | Drug | Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings |
|
| BMS-708163 | Drug | Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings |
|
| BMS-708163 | Drug | Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings |
|
| Screening, Day 1 of each period, up to 3 weeks |
| Safety: Clinical Lab Tests | Screening, Day -1 of each period, Day 1, up to 3 weeks |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |