Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
NCT ID: NCT00981968
Last Updated: 2010-10-15
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
22 participants
INTERVENTIONAL
2009-09-30
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Japanese Cohort
Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects.
Sitaxentan sodium/Placebo
100 mg and 200 mg, tablet, single and multiple oral doses for 7 days
Western Cohort
Single oral dose of sitaxentan sodium in 10 healthy subjects.
Sitaxentan sodium/Placebo
100 mg and 200 mg, tablet, single oral dose
Interventions
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Sitaxentan sodium/Placebo
100 mg and 200 mg, tablet, single and multiple oral doses for 7 days
Sitaxentan sodium/Placebo
100 mg and 200 mg, tablet, single oral dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight \>45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
Exclusion Criteria
18 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
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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B1321046
Identifier Type: -
Identifier Source: org_study_id