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

Last updated on December 17, 2017

FOR MORE INFORMATION
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.
Show details

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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Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2009
November 2009   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00981968
B1321046
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2010

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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