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Completed

NCT Number: NCT00981968

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sitaxentan sodium/Placebo

Drug

100 mg and 200 mg, tablet, single and multiple oral doses for 7 days

Other names: Thelin

Primary outcomes

  1. Adverse events (spontaneous and solicited)

    Time frame: Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2

  2. ECGs, Vital signs, Safety laboratory test

    Time frame: Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2

  3. Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F

    Time frame: Day 1 of Periods 1 and 2

  4. Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss

    Time frame: Days 1 and 7 of Periods 1 and 3

Secondary outcomes

  1. No secondary outcome

    Time frame: No secondary outcome

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2009
Registry last updated
Oct 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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