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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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-04447943
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 17
Study Start Date: August 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Experimental: Multiple dose
3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
Drug: PF-04447943
25 mg solution, oral twice daily for 7 days.
Drug: Placebo
Solution, oral twice daily for 7 days.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959803

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00959803     History of Changes
Other Study ID Numbers: B0401004
Study First Received: August 13, 2009
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Pharmacokinetics
Healthy Young Adult
Japanese
Healthy Elderly
Alzheimer disease

ClinicalTrials.gov processed this record on November 25, 2014