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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00981968
First received: September 21, 2009
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

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
Healthy
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00981968

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 22, 2014