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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04447943; Drug: Placebo

• Registration Number: NCT00959803
• Lead Sponsor: Pfizer

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-03
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single dose	Placebo	3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.
Multiple dose	Placebo	3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
Multiple dose	PF-04447943	3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects.
Single dose	PF-04447943	3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects.

Primary Outcome Measures

Name	Time	Method
AEs (spontaneous and solicited). Change from baseline in vital signs.	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.	Screening visit to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm)
Pharmacokinetic (single): AUClast, Cmax, Tmax	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.	Day 1 to day 11

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Glendale, California, United States