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

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ClinicalTrials.gov Identifier: NCT00981968
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : October 15, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Sitaxentan sodium/Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2009
Primary Completion Date : November 2009
Study Completion Date : November 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: Japanese Cohort
Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects.
Drug: Sitaxentan sodium/Placebo
100 mg and 200 mg, tablet, single and multiple oral doses for 7 days
Other Name: Thelin
Experimental: Western Cohort
Single oral dose of sitaxentan sodium in 10 healthy subjects.
Drug: Sitaxentan sodium/Placebo
100 mg and 200 mg, tablet, single oral dose
Other Name: Thelin

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. No secondary outcome [ Time Frame: No secondary outcome ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981968

United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00981968     History of Changes
Other Study ID Numbers: B1321046
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: October 15, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action