Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects
NCT ID: NCT01369836
Last Updated: 2011-09-13
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
21 participants
INTERVENTIONAL
2011-07-31
2011-08-31
Brief Summary
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* To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose.
* To compare Japanese and Western PK profiles.
* Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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20 mg soft gelatin capsule
Tafamidis meglumin
A single oral dose of 20 mg capsule
40 mg (20 mg*2) soft gelatin capsule
Tafamidis meglumin
A single oral dose of 40 mg capsule.
Placebo
Placebo
A single oral dose of matched placebo.
Interventions
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Tafamidis meglumin
A single oral dose of 20 mg capsule
Tafamidis meglumin
A single oral dose of 40 mg capsule.
Placebo
A single oral dose of matched placebo.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
Exclusion Criteria
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
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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B3461009
Identifier Type: -
Identifier Source: org_study_id
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