Study Evaluating The Coadministration of Begacestat And Donepezil

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Begacestat; Drug: Donepezil plus placebo; Drug: Donepezil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959881

B1941005

3183A1-1106

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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47 participants in 2 patient groups

Donepezil plus placebo

Experimental group

Treatment:

Drug: Donepezil plus placebo

Donepezil plus begacestat

Experimental group

Treatment:

Drug: Donepezil

Drug: Begacestat