Trial record 4 of 4 for:    GSI-953

Study Evaluating The Coadministration of Begacestat And Donepezil

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00959881
First received: August 14, 2009
Last updated: April 1, 2011
Last verified: April 2011
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters including Cmax, AUC, and t 1/2 [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00959881     History of Changes
Other Study ID Numbers: 3183A1-1106, B1941005
Study First Received: August 14, 2009
Last Updated: April 1, 2011
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014