Healthy Subjects Clinical Trial
Official title:
Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.
Status | Completed |
Enrollment | 47 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Pfizer Investigational Site | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer | Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG). | 5 months | Yes | |
Secondary | Pharmacokinetic parameters including Cmax, AUC, and t 1/2 | 5 months | Yes | |
Secondary | 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 | Yes |
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