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

December 3, 2009 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: PF-04447943
25 mg solution, oral twice daily for 7 days.
Drug: Placebo
Solution, oral twice daily for 7 days.
Experimental: Multiple dose
3:1 active PF 04447943 to placebo randomization in 8 healthy elderly 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.
Drug: PF-04447943
25 mg solution, oral twice daily for 7 days.
Drug: Placebo
Solution, oral twice daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
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)
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
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
Day 1 to day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 14, 2009

First Posted (Estimate)

August 17, 2009

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 3, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B0401004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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