Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults

May 3, 2011 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Respiratory Tract Infections

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Connecticut
  - New Haven, Connecticut, United States, 06511-5473
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 2	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 3	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 4	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 5	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 6	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 7	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 8 Japanese volunteers, low dose previously tested (based on PK)	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 9 Japanese volunteers, intermediate dose previously tested (based on PK)	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
Experimental: Cohort 10 Japanese volunteers, high dose previously tested (based on safety)	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 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Daily up to discharge, follow-up 7-10 days after dosing

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimate)

November 18, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

May 3, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Safety tolerability pharmacokinetics PK first in human FIH

Additional Relevant MeSH Terms

Other Study ID Numbers

B0581001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Respiratory Tract Infections

Clinical Trials on PF-04287881

Search Similar Trials

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Drug Interventions

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Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

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