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NCT00959881 Clinical Trial

Study Evaluating The Coadministration of Begacestat And Donepezil

Healthy Subjects Clinical Trial

Official title:
Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00959881
Other study ID # 3183A1-1106
Secondary ID B1941005
Status Completed
Phase Phase 1
First received August 14, 2009
Last updated April 1, 2011
Start date August 2009
Est. completion date November 2009

Study information
Verified date April 2011
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Donepezil plus placebo
5- and 10-mg tablets, single dose
• Donepezil
5- and 10-mg tablets, single dose
• Begacestat
6 x 50-mg capsules, single dose

Locations
Country Name City State
United States Pfizer Investigational Site Overland Park Kansas

Sponsors (2)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer Pfizer

Country where clinical trial is conducted

United States, 

Outcome
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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