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Trial record 1 of 1 for:    NCT00959881
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Study Evaluating The Coadministration of Begacestat And Donepezil

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ClinicalTrials.gov Identifier: NCT00959881
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : April 4, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE August 14, 2009
First Posted Date  ICMJE August 17, 2009
Last Update Posted Date April 4, 2011
Study Start Date  ICMJE August 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG). [ Time Frame: 5 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00959881 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2010)
  • Pharmacokinetic parameters including Cmax, AUC, and t 1/2 [ Time Frame: 5 months ]
  • Safety and tolerability as assessed by results of 12-lead ECGs, cardiac telemetry, laboratory tests, vital signs, physical examinations and reported adverse events. [ Time Frame: 5 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
Pharmacokinetic parameters including Cmax, AUC, and t 1/2; safety and tolerability as assessed by results of 12-lead ECGs, cardiac telemetry, laboratory tests, vital signs, physical examinations and reported adverse events. [ Time Frame: 5 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating The Coadministration of Begacestat And Donepezil
Official Title  ICMJE Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects
Brief Summary This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Subjects
Intervention  ICMJE
  • Drug: Donepezil plus placebo
    5- and 10-mg tablets, single dose
    Other Name: Aricept
  • Drug: Donepezil
    5- and 10-mg tablets, single dose
    Other Name: Aricept
  • Drug: Begacestat
    6 x 50-mg capsules, single dose
    Other Name: GSI-953, WAY-210953, PF-05212362
Study Arms  ICMJE
  • Experimental: Donepezil plus placebo
    Intervention: Drug: Donepezil plus placebo
  • Experimental: Donepezil plus begacestat
    Interventions:
    • Drug: Donepezil
    • Drug: Begacestat
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2010)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2009)
48
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00959881
Other Study ID Numbers  ICMJE 3183A1-1106
B1941005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP