Drug Interaction Study With a Potential Alzheimer's Disease Compound
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00726726
First received: July 30, 2008
Last updated: November 4, 2008
Last verified: November 2008
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Purpose
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 | Intervention | 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 |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
Drug Information available for:
Menadione
Warfarin
Dextromethorphan hydrobromide
Dextromethorphan
Warfarin sodium
Midazolam hydrochloride
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Pharmacokinetic effects of BMS-708163 on interacting drugs (midazolam, warfarin, caffeine, omeprazole, and dextromethorphan) [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety variables (adverse events, vital signs, safety labs) [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
| Enrollment: | 22 |
| Study Start Date: | August 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male subjects
- 18-45 yrs old inclusive
Exclusion Criteria:
- Women
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00726726 History of Changes |
| Other Study ID Numbers: | CN156-005 |
| Study First Received: | July 30, 2008 |
| Last Updated: | November 4, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Caffeine Dextromethorphan Midazolam Omeprazole Vitamin K Vitamins |
Warfarin Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents |
ClinicalTrials.gov processed this record on May 23, 2013