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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00793000

Enrollment

Registered

2008-11-18

Start date

2008-11-30

Completion date

2009-12-31

Last updated

2011-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Tract Infections

Keywords

Safety tolerability pharmacokinetics PK first in human FIH

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.

Interventions

DRUGPF-04287881

75 mg oral dose (prepared solution) given once

DRUGPlacebo

placebo to match 75 mg oral dose (prepared solution), given once

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026