A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers
NCT ID: NCT01051232
Last Updated: 2010-04-26
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
24 participants
INTERVENTIONAL
2010-02-28
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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Cohort 1
PF-00868554 (filibuvir) 100 mg or placebo
Active
Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
Placebo
Two subjects will receive the placebo under fasting condition.
Cohort 2
PF-00868554 (filibuvir) 300 mg or placebo
Active
Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
Placebo
Two subjects will receive the placebo under fasting condition.
Cohort 3
PF-00868554 (filibuvir) 500 mg or placebo
Active
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
Placebo
Two subjects will receive the placebo under fasting condition.
Interventions
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Active
Six subjects will receive PF-00868554 (filibuvir) 100 mg under fasting condition.
Placebo
Two subjects will receive the placebo under fasting condition.
Active
Six subjects will receive PF-00868554 (filibuvir) 300 mg under fasting condition.
Placebo
Two subjects will receive the placebo under fasting condition.
Active
Six subjects will receive PF-00868554 (filibuvir) 500 mg under fasting condition.
Placebo
Two subjects will receive the placebo under fasting condition.
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.
Exclusion Criteria
* Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
* Pregnant or nursing females; females of childbearing potential.
20 Years
55 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
Shinjuku-ku, Tokyo, Japan
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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A8121035
Identifier Type: -
Identifier Source: org_study_id
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