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.

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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).

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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	PF-04287881	-
Cohort 5	Placebo	-
Cohort 6	PF-04287881	-
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	PF-04287881	Japanese volunteers, intermediate dose previously tested (based on PK)
Cohort 9	Placebo	Japanese volunteers, intermediate dose previously tested (based on PK)
Cohort 10	PF-04287881	Japanese volunteers, high dose previously tested (based on safety)
Cohort 10	Placebo	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