Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Sitaxsentan

Criteria

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.