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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PF-04447943

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959803

B0401004

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Single dose

Experimental group

Description:

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

Treatment:

Drug: PF-04447943

Drug: PF-04447943

Drug: PF-04447943

Drug: Placebo

Drug: Placebo

Drug: PF-04447943

Multiple dose

Experimental group

Description:

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

Treatment:

Drug: PF-04447943

Drug: PF-04447943

Drug: PF-04447943

Drug: Placebo

Drug: Placebo

Drug: PF-04447943