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Drug-Drug Interaction Study With Aricept® (Donepezil)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042314
First Posted: January 5, 2010
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bristol-Myers Squibb
  Purpose
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 Intervention Phase
Alzheimer Disease Drug: Donepezil Drug: BMS-708163 Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 18
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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
United States, Maryland
Parexel International - Baltimore Epcu
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01042314     History of Changes
Other Study ID Numbers: CN156-008
First Submitted: December 22, 2009
First Posted: January 5, 2010
Last Update Posted: January 25, 2011
Last Verified: April 2010

Additional relevant MeSH terms:
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