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Interacting drugs- Cooperstown Cocktail

Phase 1

Alzheimer Disease | Small molecule | Neurology |Bristol-Myers Squibb Company|Last Updated: Nov 5, 2008

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

Interacting drugs- Cooperstown Cocktail · 1 trial · 1 indication

Phase 1 1
NCT00726726Drug Interaction Study With a Potential Alzheimer's Disease CompoundAlzheimer Disease
COMPLETED22 Analytics
PHASE1COMPLETED
Drug Interaction Study With a Potential Alzheimer's Disease Compound
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetic effects of BMS-708163 on interacting drugs (midazolam, warfarin, caffeine, omeprazole, and dextromethorphan)
throughout the study

Secondary Endpoints

Safety variables (adverse events, vital signs, safety labs)
throughout the study
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AOTHER -
BEXPERIMENTAL -
CEXPERIMENTAL\+ Other

Interventions

NameTypeDescription
Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)DRUGCapsules + 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-708163DRUGCapsules, Oral, 150 mg, once daily, days 6-15, 10 Days
BMS-708163 + Cooperstown CocktailDRUGCapsules + 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
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subjects * 18-45 yrs old inclusive Exclusion Criteria: * Women

Countries:United States
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