NCT01026545

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

A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After Administration Of Multiple Escalating Oral Doses To Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Following a Serious Adverse Event (potential Hy's Law case), a risk-benefit assessment review of all preliminary safety data, and a review by Pfizer's internal hepatic injury advisory panel, it was concluded that PF-04287881 had an unacceptable therapeutic window. The FDA was notified of our intention to discontinue development as of 09April2010.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-12-04
• Last updated: 2011-05-04

Locations

1 site across 1 country: United States