Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

Phase 1

Completed

• Conditions: Respiratory Tract Infections
• Interventions: Drug: PF-04287881; Drug: Placebo

• Registration Number: NCT00793000
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-12
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-03
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
• Women of non-childbearing potential only.
• Japanese subjects muct have 4 Japanese grandparents who were born in Japan.

Exclusion Criteria

• Previous antibiotic use within 14 days prior to dosing.
• Use of antibiotics during hospitalization within 90 days prior to dosing.
• History of sensitivity to macrolides or ketolides.
• Presence of clinically significant eye conditions (other than corrective lenses).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	PF-04287881	-
Cohort 1	Placebo	-
Cohort 2	PF-04287881	-
Cohort 2	Placebo	-
Cohort 3	PF-04287881	-
Cohort 3	Placebo	-
Cohort 4	PF-04287881	-
Cohort 4	Placebo	-
Cohort 5	Placebo	-
Cohort 6	Placebo	-
Cohort 7	PF-04287881	-
Cohort 7	Placebo	-
Cohort 8	PF-04287881	Japanese volunteers, low dose previously tested (based on PK)
Cohort 8	Placebo	Japanese volunteers, low dose previously tested (based on PK)
Cohort 9	Placebo	Japanese volunteers, intermediate dose previously tested (based on PK)
Cohort 10	Placebo	Japanese volunteers, high dose previously tested (based on safety)
Cohort 5	PF-04287881	-
Cohort 6	PF-04287881	-
Cohort 9	PF-04287881	Japanese volunteers, intermediate dose previously tested (based on PK)
Cohort 10	PF-04287881	Japanese volunteers, high dose previously tested (based on safety)

Primary Outcome Measures

Name	Time	Method
Evaluation of safety and tolerability of PF-04287881 after single oral dose.	Daily up to discharge, follow-up 7-10 days after dosing

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of PF-04287881 after a single oral dose.	Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States