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Drug-Drug Interaction Study With Aricept® (Donepezil)

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ClinicalTrials.gov Identifier: NCT01042314
Recruitment Status : Completed
First Posted : January 5, 2010
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to find out if the plasma concentration of donepezil is changed when BMS-708163 is administered at the same time

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Donepezil Drug: BMS-708163 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study of the Effect of Concomitant Administration of BMS-708163 on the Pharmacokinetics of Donepezil in Healthy Subjects
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Donepezil and BMS-708163 Drug: Donepezil
Tablets, Oral, 5 mg, Once Daily, Days 1-28
Other Name: Aricept®

Drug: BMS-708163
Capsule, Oral, 125 mg, Once Daily, Days 15-28


Outcome Measures
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Primary Outcome Measures :
  1. Aricept® alone and with BMS-708163: Aricept® Multiple-dose pharmacokinetic parameters (Cmax, Tmax, AUC (TAU), and Ctrough) will be assessed without BMS-708163 on Day 14 and with BMS-708163 (Ctrough) on Day 28 [ Time Frame: Days 14 and 28 ]

Secondary Outcome Measures :
  1. Aricept® alone and with BMS-708163: Safety and tolerability based on adverse events, ECG, vital signs and safety labs [ Time Frame: Days 7, 14, 21, 29 and study discharge ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy men and postmenopausal women

Exclusion Criteria:

  • Medical History and Concurrent Diseases
  • Gastrointestinal disease
  • Gastrointestinal bleeding disorders
  • History of peptic ulcer disease
  • History of cholecystectomy
  • History of seizure disorder
  • History of asthma
  • History of Chronic Obstructive Pulmonary Disease
  • History of cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes
  • Inability to tolerate oral medication
  • Inability to be venipunctured and/or tolerate venous access
Contacts and Locations
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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): NCT01042314


Locations
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United States, Maryland
Parexel International - Baltimore Epcu
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01042314    
Other Study ID Numbers: CN156-008
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: April 2010
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents