Drug-Drug Interaction Study With Aricept® (Donepezil)

This study has been completed.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: December 22, 2009
Last updated: January 24, 2011
Last verified: April 2010
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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042314

United States, Maryland
Parexel International - Baltimore Epcu
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Bristol-Myers Squibb
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 
Study First Received: December 22, 2009
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2016