Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects
NCT ID: NCT01159626
Last Updated: 2011-04-20
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
40 participants
INTERVENTIONAL
2010-07-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Single dose
PF-03463275
Oral single 20 mg dose as two 10mg controlled release tablets
PF-03463275
Oral single 40 mg dose as four 10mg controlled release tablets
PF-03463275
Oral single 60 mg dose as six 10mg controlled release tablets
Placebo
Oral single dose as matching placebo
Multiple dose
PF-03463275
Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days
Placebo
Oral multiple doses as matching placebo for 7 days
Interventions
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PF-03463275
Oral single 20 mg dose as two 10mg controlled release tablets
PF-03463275
Oral single 40 mg dose as four 10mg controlled release tablets
PF-03463275
Oral single 60 mg dose as six 10mg controlled release tablets
Placebo
Oral single dose as matching placebo
PF-03463275
Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days
Placebo
Oral multiple doses as matching placebo for 7 days
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).
* Japanese subjects must have four Japanese grandparents who were born in Japan.
Exclusion Criteria
* Evidence or history of clinically significant hematological (including anemia), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
18 Years
55 Years
MALE
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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A9131010
Identifier Type: -
Identifier Source: org_study_id
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