Drug-Drug Interaction Study With Aricept® (Donepezil)

NCT ID: NCT01042314

Last Updated: 2011-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Donepezil and BMS-708163

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

Tablets, Oral, 5 mg, Once Daily, Days 1-28

BMS-708163

Intervention Type DRUG

Capsule, Oral, 125 mg, Once Daily, Days 15-28

Interventions

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Donepezil

Tablets, Oral, 5 mg, Once Daily, Days 1-28

Intervention Type DRUG

BMS-708163

Capsule, Oral, 125 mg, Once Daily, Days 15-28

Intervention Type DRUG

Other Intervention Names

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Aricept®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Parexel International - Baltimore Epcu

Baltimore, Maryland, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CN156-008

Identifier Type: -

Identifier Source: org_study_id

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