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Trial record 1 of 1 for:    NCT00959803
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Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.

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ClinicalTrials.gov Identifier: NCT00959803
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 13, 2009
First Posted Date  ICMJE August 17, 2009
Last Update Posted Date December 7, 2009
Study Start Date  ICMJE August 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • AEs (spontaneous and solicited). Change from baseline in vital signs. [ Time Frame: Day 0 to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm) ]
  • ECG and clinical safety laboratory endpoints, including a complete blood count, a full chemistry panel (including electrolytes and hepatic transaminases) and urinalysis. [ Time Frame: Screening visit to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm) ]
  • Pharmacokinetic (single): AUClast, Cmax, Tmax [ Time Frame: Day 1 to day 5 ]
  • Pharmacokinetic(multiple): AUCt, Cmax and Tmax on Days 1 and 7, and Ctrough on Days 2, 3, 4 and 7. [ Time Frame: Day 1 to day 11 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.
Official Title  ICMJE An Investigator- And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04447943 After Administration Of Single Oral Doses To Healthy Young Adult Japanese Subjects And Multiple Oral Doses To Healthy Elderly Japanese Subjects
Brief Summary This study is designed to investigate the safety, tolerability, and pharmacokinetics of PF-04447943 after single and multiple-dose administration to healthy young adult and elderly Japanese subjects, respectively.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04447943
    3 mg solution, oral single dose.
  • Drug: PF-04447943
    10 mg solution, oral single dose.
  • Drug: PF-04447943
    25 mg solution, oral single dose.
  • Drug: Placebo
    Solution, oral single dose.
  • Drug: PF-04447943
    25 mg solution, oral twice daily for 7 days.
  • Drug: Placebo
    Solution, oral twice daily for 7 days.
Study Arms  ICMJE
  • Experimental: Single dose
    3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.
    Interventions:
    • Drug: PF-04447943
    • Drug: PF-04447943
    • Drug: PF-04447943
    • Drug: Placebo
  • Experimental: Multiple dose
    3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
    Interventions:
    • Drug: PF-04447943
    • Drug: 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: August 14, 2009)
17
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:

  • For young cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 18 and 55 years, inclusive.
  • For elderly cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 65 and 85 years, inclusive.
  • Body Mass Index (BMI) between 17.5 to 30.5 kg/m2, and a total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Pregnant or nursing women; women of childbearing potential.
  • Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older 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 NCT00959803
Other Study ID Numbers  ICMJE B0401004
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 December 2009

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