Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.
NCT ID: NCT00959803
Last Updated: 2009-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
17 participants
INTERVENTIONAL
2009-08-31
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Single dose
3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.
PF-04447943
3 mg solution, oral single dose.
PF-04447943
10 mg solution, oral single dose.
PF-04447943
25 mg solution, oral single dose.
Placebo
Solution, oral single dose.
Multiple dose
3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
PF-04447943
25 mg solution, oral twice daily for 7 days.
Placebo
Solution, oral twice daily for 7 days.
Interventions
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PF-04447943
3 mg solution, oral single dose.
PF-04447943
10 mg solution, oral single dose.
PF-04447943
25 mg solution, oral single dose.
Placebo
Solution, oral single dose.
PF-04447943
25 mg solution, oral twice daily for 7 days.
Placebo
Solution, oral twice daily for 7 days.
Eligibility Criteria
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Inclusion Criteria
* For elderly cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 65 and 85 years, inclusive.
* Body Mass Index (BMI) between 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).
Exclusion Criteria
* Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.
18 Years
85 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Glendale, California, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B0401004
Identifier Type: -
Identifier Source: org_study_id