NCT00793000

Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	PF-04287881	75 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 75 mg oral dose (prepared solution), given once
DRUG	PF-04287881	150 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 150 mg oral dose (prepared solution), given once
DRUG	PF-04287881	300 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 300 mg oral dose (prepared solution), given once
DRUG	PF-04287881	750 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 750 mg oral dose (prepared solution), given once
DRUG	PF-04287881	1000 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 1000 mg oral dose (prepared solution), given once
DRUG	PF-04287881	1250 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 1250 mg oral dose (prepared solution), given once
DRUG	PF-04287881	1500 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 1500 mg oral dose (prepared solution), given once
DRUG	PF-04287881	300 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 300 mg oral dose (prepared solution), given once
DRUG	PF-04287881	750 mg oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 750 mg oral dose (prepared solution), given once
DRUG	PF-04287881	1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
DRUG	Placebo	placebo to match 1000 mg oral dose (prepared solution), given once

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-11-18
• Last updated: 2011-05-04

Locations

1 site across 1 country: United States