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Trial record 1 of 1 for:    NCT00981968
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Phase 1, Single and Multiple Doses Study of Sitaxentan in Japanese and Western Subjects

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ClinicalTrials.gov Identifier: NCT00981968
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : October 15, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 21, 2009
First Posted Date  ICMJE September 22, 2009
Last Update Posted Date October 15, 2010
Study Start Date  ICMJE September 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2009)
  • 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 ]
  • 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 ]
  • Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F [ Time Frame: Day 1 of Periods 1 and 2 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2009)
No secondary outcome [ Time Frame: No secondary outcome ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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.
Detailed Description Not 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 Date November 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 Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP