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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00959803
First received: August 13, 2009
Last updated: December 3, 2009
Last verified: December 2009

August 13, 2009
December 3, 2009
August 2009
November 2009   (final data collection date for primary outcome measure)
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (single): AUClast, Cmax, Tmax [ Time Frame: Day 1 to day 5 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00959803 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00959803
B0401004
No
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