We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating The Coadministration of Begacestat And Donepezil

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959881
First Posted: August 17, 2009
Last Update Posted: April 4, 2011
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.
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.

Condition Intervention Phase
Healthy Subjects Drug: Donepezil plus placebo Drug: Donepezil Drug: Begacestat Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 47
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00959881


Locations
United States, Kansas
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
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00959881     History of Changes
Other Study ID Numbers: 3183A1-1106
B1941005
First Submitted: August 14, 2009
First Posted: August 17, 2009
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:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents