Status:
COMPLETED
Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00981968
Start Date
September 1 2009
End Date
November 1 2009
Last Update
October 15 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Glendale, California, United States, 91206