PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions
NCT ID: NCT01362673
Last Updated: 2011-10-07
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
27 participants
INTERVENTIONAL
2011-05-31
2011-08-31
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-04171327
Oral single 5 mg dose as one 5 mg tablet
PF-04171327
Oral single 10 mg dose as one 10 mg tablet
PF-04171327
Oral single 30 mg dose as three 10 mg tablets
Placebo
Oral single dose as matching placebo
Multiple dose
PF-04171327
Oral multiple 20 mg doses as two 10 mg tablets for 12 days
Placebo
Oral multiple doses as matching placebo for 12 days
Interventions
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PF-04171327
Oral single 5 mg dose as one 5 mg tablet
PF-04171327
Oral single 10 mg dose as one 10 mg tablet
PF-04171327
Oral single 30 mg dose as three 10 mg tablets
Placebo
Oral single dose as matching placebo
PF-04171327
Oral multiple 20 mg doses as two 10 mg tablets for 12 days
Placebo
Oral multiple doses as matching placebo for 12 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 \>45 kg (99 lbs).
* Japanese subjects who have four Japanese grandparents born in Japan.
Exclusion Criteria
* Corticosteroid use of more than 5 mg prednisone equivalent per day for more than 6 weeks.
* 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 the time of dosing).
18 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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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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A9391012
Identifier Type: -
Identifier Source: org_study_id