Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.

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NCT00959803

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Study Location
Pfizer Investigational Site
Glendale, California, 91206, United States
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Contact
1-800-718-1021
[email protected]
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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
18-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 CenterPfizer
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