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Interacting drugs- Cooperstown Cocktail · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| A | OTHER | - |
| B | EXPERIMENTAL | - |
| C | EXPERIMENTAL | \+ Other |
| Name | Type | Description |
|---|---|---|
| Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan) | DRUG | Capsules + Tablets + Oral solution, Oral, Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg once daily, Day 1, 1 Day |
| BMS-708163 | DRUG | Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days |
| BMS-708163 + Cooperstown Cocktail | DRUG | Capsules + tablets + Oral solution, Oral, BMS-708163: 150 mg + Midazolam: 5 mg, Warfarin: 10 mg (vitamin K 10 mg), caffeine: 200 mg, omeprazole: 40 mg, dextromethorphan: 30 mg, BMS-708163, once daily, days 16-20 midazolam,warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan once daily on Day 16, 5 Days |
Inclusion Criteria: * Healthy male subjects * 18-45 yrs old inclusive Exclusion Criteria: * Women
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The Cooperstown Cocktail is a combination of interacting drugs, specifically midazolam, warfarin with vitamin K, caffeine, omeprazole, and dextromethorphan. It is used in a Phase 1 drug interaction study to assess how a potential Alzheimer's disease compound affects these probe substrates. Bristol-Myers Squibb Company (BMY) developed this cocktail for the study.
The Cooperstown Cocktail is used in a Phase 1 drug interaction study for Alzheimer disease. It serves as a probe cocktail to evaluate potential interactions between a developmental Alzheimer's compound and the individual drugs in the cocktail. The study was completed and enrolled 22 healthy male volunteers.
Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of the Cooperstown Cocktail. The company sponsored the Phase 1 drug interaction study evaluating this cocktail in healthy volunteers.
The Cooperstown Cocktail is in Phase 1 development. It was evaluated in a single completed Phase 1 drug interaction study. It is not an approved product and remains investigational.
The Cooperstown Cocktail was studied in one completed clinical trial, NCT00726726, titled "Drug Interaction Study With a Potential Alzheimer's Disease Compound." This Phase 1 trial enrolled 22 healthy male volunteers in the United States and was controlled but not randomized or double-blinded.