Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects
Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
Participant gender:
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.