Study Evaluating The Coadministration of Begacestat And Donepezil
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT00959881
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Donepezil plus placebo Donepezil plus placebo - Donepezil plus begacestat Donepezil - Donepezil plus begacestat Begacestat -
- Primary Outcome Measures
Name Time Method Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG). 5 months
- Secondary Outcome Measures
Name Time Method Safety and tolerability as assessed by results of 12-lead ECGs, cardiac telemetry, laboratory tests, vital signs, physical examinations and reported adverse events. 5 months Pharmacokinetic parameters including Cmax, AUC, and t 1/2 5 months
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Overland Park, Kansas, United States