Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects

Summary

This study is a randomized, investigator blind, subject blind, sponsor-open, placebo controlled, multiple dose escalating, sequential, parallel cohort study of PF-04287881. Subjects will undergo screening procedures within 28 days prior to dosing. At least 1 day after the Screening visit, eligible subjects who meet the entry criteria will be admitted to the Clinical Research Unit (CRU) and confined in the unit until discharge on Day 15.

Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6), 18 to 55 years of age, males and females (women of non childbearing potential only) will be enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within each cohort. Each cohort will have a 10 day dosing period and each will consist of 10 subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily oral dose of either placebo or PF-04287881 under fasted state for 10 days.

Conditions

• Respiratory Tract Infections

Interventions

DRUG

PF-04287881

500 mg once daily for 10 days

DRUG

Placebo

To match 500 mg dose once daily for 10 days

DRUG

PF-04287881

750 mg once daily for 10 days

DRUG

Placebo

To match 750 mg dose once daily for 10 days

DRUG

PF-04287881

1100 mg once daily for 10 days

DRUG

Placebo

To match 1100 mg dose once daily for 10 days

DRUG

PF-04287881

Optional cohort with dose not greater than 1100 mg

DRUG

Placebo

Optional cohort to match dose not greater than 1100 mg

DRUG

PF-04287881

750 mg dose once daily for 10 days

DRUG

Placebo

To match 750 mg dose once daily for 10 days

DRUG

PF-04287881

1100 mg dose once daily for 10 days

DRUG

Placebo

To match 1100 mg dose once daily for 10 days

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-12-31

Primary Completion

2010-07-31

Completion

2010-07-31

Countries

• United States

Study Locations