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Drug Interaction Study With a Potential Alzheimer's Disease Compound

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ClinicalTrials.gov Identifier: NCT00726726
Recruitment Status : Completed
First Posted : August 1, 2008
Last Update Posted : November 5, 2008
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan) Drug: BMS-708163 Drug: BMS-708163 + Cooperstown Cocktail Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008


Arm Intervention/treatment
A Drug: Interacting drugs - Cooperstown Cocktail (midazolam, warfarin, (+ vitamin K), caffeine, omeprazole and dextromethorphan)
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
Experimental: B Drug: BMS-708163
Capsules, Oral, 150 mg, once daily, days 6-15, 10 Days
Experimental: C
+ Other
Drug: BMS-708163 + Cooperstown Cocktail
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 Measures :
  1. Pharmacokinetic effects of BMS-708163 on interacting drugs (midazolam, warfarin, caffeine, omeprazole, and dextromethorphan) [ Time Frame: throughout the study ]

Secondary Outcome Measures :
  1. Safety variables (adverse events, vital signs, safety labs) [ Time Frame: throughout the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects
  • 18-45 yrs old inclusive

Exclusion Criteria:

  • Women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00726726


Locations
United States, New Jersey
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, United States, 08690
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00726726     History of Changes
Other Study ID Numbers: CN156-005
First Posted: August 1, 2008    Key Record Dates
Last Update Posted: November 5, 2008
Last Verified: November 2008

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Vitamins
Vitamin K
Midazolam
Caffeine
Dextromethorphan
Warfarin
Omeprazole
Micronutrients
Growth Substances
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents