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Completed

NCT Number: NCT00959881

Study Evaluating The Coadministration of Begacestat And Donepezil

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

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Key information

Conditions

Healthy Subjects Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Overland Park, Kansas, 66211, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donepezil plus placebo

Drug

5- and 10-mg tablets, single dose

Other names: Aricept

Donepezil

Drug

5- and 10-mg tablets, single dose

Other names: Aricept

Begacestat

Drug

6 x 50-mg capsules, single dose

Other names: GSI-953, WAY-210953, PF-05212362

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Collaborators

  • Pfizer

Registry information

Official study title

Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Aug 17, 2009
Registry last updated
Apr 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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