Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
- Registration Number
- NCT00981968
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Healthy male and/or female subjects between the age of 18 and 55 years, inclusive.
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
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Japanese Cohort Sitaxentan sodium/Placebo Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects. Western Cohort Sitaxentan sodium/Placebo Single oral dose of sitaxentan sodium in 10 healthy subjects.
- Primary Outcome Measures
Name Time Method Adverse events (spontaneous and solicited) Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2 ECGs, Vital signs, Safety laboratory test Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2 Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F Day 1 of Periods 1 and 2 Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss Days 1 and 7 of Periods 1 and 3
- Secondary Outcome Measures
Name Time Method No secondary outcome No secondary outcome
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Glendale, California, United States