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

Pfizer17 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-04447943DRUG

3 mg solution, oral single dose.

PF-04447943DRUG

10 mg solution, oral single dose.

PF-04447943DRUG

25 mg solution, oral single dose.

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

Glendale, California, United States

Outcomes

Primary Outcomes

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)

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)

Pharmacokinetic (single): AUClast, Cmax, Tmax

Time frame: 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

Data from ClinicalTrials.gov

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