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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00981968
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
2
Duration (Months)
11
Patients Per Site Per Month

Study Details

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
  • Drug: Sitaxentan sodium/Placebo
  • Drug: Sitaxentan sodium/Placebo
 Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 1, 2009
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 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 Names:
  • 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 Names:
  • Thelin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events (spontaneous and solicited) [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 [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 [Day 1 of Periods 1 and 2]

    4. Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss [Days 1 and 7 of Periods 1 and 3]

    Secondary Outcome Measures

    1. No secondary outcome [No secondary outcome]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    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

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Glendale California United States 91206

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00981968
    Other Study ID Numbers:
    • B1321046
    First Posted:
    Sep 22, 2009
    Last Update Posted:
    Oct 15, 2010
    Last Verified:
    Oct 1, 2010
    Additional relevant MeSH terms:
    Sitaxsentan

    Study Results

    No Results Posted as of Oct 15, 2010