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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00981968

Run by

Pfizer

People needed

22

Starts

2009-09-01

Expected to finish

2009-11-01

Last updated by the study team

2010-10-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.

Where it is running

• Pfizer Investigational Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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