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Completed

NCT Number: NCT00793000

Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

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.

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Key information

Conditions

Respiratory Tract Infections Infections Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PF-04287881

Drug

75 mg oral dose (prepared solution) given once

Placebo

Drug

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

Primary outcomes

  1. Evaluation of safety and tolerability of PF-04287881 after single oral dose.

    Time frame: Daily up to discharge, follow-up 7-10 days after dosing

Secondary outcomes

  1. Pharmacokinetics of PF-04287881 after a single oral dose.

    Time frame: Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 18, 2008
Registry last updated
May 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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