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Trial record 70 of 332 for:    DONEPEZIL

Study Evaluating The Coadministration of Begacestat And Donepezil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00959881
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : April 4, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Donepezil plus placebo Drug: Donepezil Drug: Begacestat Phase 1

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Study Type : Interventional  (Clinical Trial)
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 : August 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: Donepezil plus placebo Drug: Donepezil plus placebo
5- and 10-mg tablets, single dose
Other Name: Aricept

Experimental: Donepezil plus begacestat 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

Primary Outcome Measures :
  1. Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG). [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters including Cmax, AUC, and t 1/2 [ Time Frame: 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. [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00959881

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United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00959881    
Other Study ID Numbers: 3183A1-1106
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: April 4, 2011
Last Verified: April 2011
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Alzheimer Disease
Additional relevant MeSH terms:
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Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents