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

NCT ID: NCT00959803

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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Healthy

Keywords

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Phase 1 Pharmacokinetics Healthy Young Adult Japanese Healthy Elderly Alzheimer disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single dose

3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.

Group Type EXPERIMENTAL

PF-04447943

Intervention Type DRUG

3 mg solution, oral single dose.

PF-04447943

Intervention Type DRUG

10 mg solution, oral single dose.

PF-04447943

Intervention Type DRUG

25 mg solution, oral single dose.

Placebo

Intervention Type DRUG

Solution, oral single dose.

Multiple dose

3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.

Group Type EXPERIMENTAL

PF-04447943

Intervention Type DRUG

25 mg solution, oral twice daily for 7 days.

Placebo

Intervention Type DRUG

Solution, oral twice daily for 7 days.

Interventions

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PF-04447943

3 mg solution, oral single dose.

Intervention Type DRUG

PF-04447943

10 mg solution, oral single dose.

Intervention Type DRUG

PF-04447943

25 mg solution, oral single dose.

Intervention Type DRUG

Placebo

Solution, oral single dose.

Intervention Type DRUG

PF-04447943

25 mg solution, oral twice daily for 7 days.

Intervention Type DRUG

Placebo

Solution, oral twice daily for 7 days.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Glendale, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B0401004

Identifier Type: -

Identifier Source: org_study_id