Study Evaluating The Coadministration of Begacestat And Donepezil

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

Brief Summary

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This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Donepezil plus placebo

Group Type EXPERIMENTAL

Donepezil plus placebo

Intervention Type DRUG

5- and 10-mg tablets, single dose

Donepezil plus begacestat

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

5- and 10-mg tablets, single dose

Begacestat

Intervention Type DRUG

6 x 50-mg capsules, single dose

Interventions

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Donepezil plus placebo

5- and 10-mg tablets, single dose

Intervention Type DRUG

Donepezil

5- and 10-mg tablets, single dose

Intervention Type DRUG

Begacestat

6 x 50-mg capsules, single dose

Intervention Type DRUG

Other Intervention Names

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Aricept Aricept GSI-953, WAY-210953, PF-05212362

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Men and women of non-childbearing potential
* Non smoker or smoker of \<10 cigarettes per day and able to refrain from smoking during study
* 18-50 years old

Exclusion Criteria

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Cardiac rhythm abnormalities
* Family history of cardiac risk factors

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes