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Study Evaluating The Coadministration of Begacestat And Donepezil

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00959881
Collaborator
Pfizer (Industry)
47
Enrollment
1
Location
2
Arms
3
Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects
Study Start Date :
Aug 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Donepezil plus placebo

Drug: Donepezil plus placebo
5- and 10-mg tablets, single dose
Other Names:
  • Aricept

    		•
    Experimental: Donepezil plus begacestat

    Drug: Donepezil
    5- and 10-mg tablets, single dose
    Other Names:
  • Aricept

    • Drug: Begacestat
    6 x 50-mg capsules, single dose
    Other Names:
  • GSI-953, WAY-210953, PF-05212362

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Pharmacokinetic parameters including Cmax, AUC, and t 1/2 [5 months]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Overland Park Kansas United States 66211

    Sponsors and Collaborators

    • Wyeth is now a wholly owned subsidiary of Pfizer
    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00959881
    Other Study ID Numbers:
    • 3183A1-1106
    • B1941005
    First Posted:
    Aug 17, 2009
    Last Update Posted:
    Apr 4, 2011
    Last Verified:
    Apr 1, 2011
    Keywords provided by , ,
    Alzheimer Disease
    Additional relevant MeSH terms:
    Donepezil

    Study Results

    No Results Posted as of Apr 4, 2011