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

Last updated on December 4, 2019

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Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00981968
Pfizer
Completed
Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects

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Descriptive Information
Brief Title  ICMJE Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
Official Title  ICMJE 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
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Sitaxentan sodium/Placebo
    100 mg and 200 mg, tablet, single and multiple oral doses for 7 days
    Other Name: Thelin
  • Drug: Sitaxentan sodium/Placebo
    100 mg and 200 mg, tablet, single oral dose
    Other Name: Thelin
Study Arms  ICMJE
  • Experimental: Japanese Cohort
    Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects.
    Intervention: Drug: Sitaxentan sodium/Placebo
  • Experimental: Western Cohort
    Single oral dose of sitaxentan sodium in 10 healthy subjects.
    Intervention: Drug: Sitaxentan sodium/Placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2009)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion DateNovember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00981968
Other Study ID Numbers  ICMJE B1321046
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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