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

Last updated on May 11, 2018

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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
18-85 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.

NCT00959803
Pfizer
Completed
Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.

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Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
November 2009
November 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00959803
B0401004
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2009

ICMJE     Data element required by the

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

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