Drug Interaction Study With a Potential Alzheimer's Disease Compound

Phase 1

Completed

• Conditions: Alzheimer Disease
• Interventions: Drug: Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan); Drug: BMS-708163; Drug: BMS-708163 + Cooperstown Cocktail

• Registration Number: NCT00726726
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine whether BMS-708163 will effect the pharmacokinetics of the commonly prescribed medicines midazolam, warfarin, caffeine,omeprazole and dextromethorphan

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study Start: 2008-08
• Study First Posted: 2008-08-01
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-04
• Last Update Posted: 2008-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 22

Inclusion Criteria

• Healthy male subjects
• 18-45 yrs old inclusive

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Exclusion Criteria

• Women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)	-
B	BMS-708163	-
C	BMS-708163 + Cooperstown Cocktail	+ Other

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety variables (adverse events, vital signs, safety labs)	throughout the study

Trial Locations

Locations (1)

Bristol-Myers Squibb Clinical Pharmacology Unit; 🇺🇸 Hamilton, New Jersey, United States