Study Evaluating The Coadministration of Begacestat And Donepezil
Combined Administration Of Begacestat And Donepezil: A Multiple-Dose Study In Healthy Subjects
2 other identifiers
interventional
47
1 country
1
Brief Summary
This study examines the cardiac effects (effects on the heart) of administering donepezil and begacestat together to healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedApril 4, 2011
April 1, 2011
3 months
August 14, 2009
April 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacodynamic interaction of multiple doses of begacestat and donepezil coadministered to healthy subjects as assessed by 12-lead electrocardiogram (ECG).
5 months
Secondary Outcomes (2)
Pharmacokinetic parameters including Cmax, AUC, and t 1/2
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.
5 months
Study Arms (2)
Donepezil plus placebo
EXPERIMENTALDonepezil plus begacestat
EXPERIMENTALInterventions
5- and 10-mg tablets, single dose
6 x 50-mg capsules, single dose
Eligibility Criteria
You may qualify if:
- 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
- years old
You may not qualify if:
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Cardiac rhythm abnormalities
- Family history of cardiac risk factors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizerlead
- Pfizercollaborator
Study Sites (1)
Pfizer Investigational Site
Overland Park, Kansas, 66211, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 17, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
April 4, 2011
Record last verified: 2011-04