Back to resultsDrug Interaction Study With a Potential Alzheimer's Disease Compound
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)
BMS-708163
BMS-708163 + Cooperstown Cocktail
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy male subjects
- 18-45 yrs old inclusive
Exclusion Criteria:
- Women
Sites / Locations
- Bristol-Myers Squibb Clinical Pharmacology Unit
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
A
B
C
Arm Description
+ Other
Outcomes
Primary Outcome Measures
Pharmacokinetic effects of BMS-708163 on interacting drugs (midazolam, warfarin, caffeine, omeprazole, and dextromethorphan)
Secondary Outcome Measures
Safety variables (adverse events, vital signs, safety labs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00726726
Brief Title
Drug Interaction Study With a Potential Alzheimer's Disease Compound
Official Title
Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Midazolam, Warfarin, Caffeine, Omeprazole and Dextromethorphan in Healthy Male Subjects by Administration of a Modified Cooperstown Cocktail
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Title
B
Arm Type
Experimental
Arm Title
C
Arm Type
Experimental
Arm Description
+ Other
Intervention Type
Drug
Intervention Name(s)
Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
BMS-708163
Intervention Description
Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days
Intervention Type
Drug
Intervention Name(s)
BMS-708163 + Cooperstown Cocktail
Intervention Description
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
Primary Outcome Measure Information:
Title
Pharmacokinetic effects of BMS-708163 on interacting drugs (midazolam, warfarin, caffeine, omeprazole, and dextromethorphan)
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Safety variables (adverse events, vital signs, safety labs)
Time Frame
throughout the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male subjects
18-45 yrs old inclusive
Exclusion Criteria:
Women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Bristol-Myers Squibb Clinical Pharmacology Unit
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Drug Interaction Study With a Potential Alzheimer's Disease Compound
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