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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 21, 2009
Last updated: October 14, 2010
Last verified: October 2010
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 Intervention Phase
Drug: Sitaxentan sodium/Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F [ Time Frame: Day 1 of Periods 1 and 2 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcome [ Time Frame: No secondary outcome ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00981968

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00981968     History of Changes
Other Study ID Numbers: B1321046 
Study First Received: September 21, 2009
Last Updated: October 14, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on October 25, 2016