Multiple Oral Dose Safety, Tolerability And Pharmacokinetic Study Of PF-04287881 In Healthy Adult Subjects

May 3, 2011 updated by: Pfizer

A Phase 1, Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After Administration Of Multiple Escalating Oral Doses To Healthy Adult Subjects

This study is a randomized, investigator blind, subject blind, sponsor-open, placebo controlled, multiple dose escalating, sequential, parallel cohort study of PF-04287881. Subjects will undergo screening procedures within 28 days prior to dosing. At least 1 day after the Screening visit, eligible subjects who meet the entry criteria will be admitted to the Clinical Research Unit (CRU) and confined in the unit until discharge on Day 15.

Approximately 60 healthy volunteers (20 volunteers of Japanese origin for Cohorts 5 and 6), 18 to 55 years of age, males and females (women of non childbearing potential only) will be enrolled and randomized in a 4:1 ratio to treatment with either PF-04287881 or placebo within each cohort. Each cohort will have a 10 day dosing period and each will consist of 10 subjects (8 active and 2 placebo). In each cohort, each subject will receive a single daily oral dose of either placebo or PF-04287881 under fasted state for 10 days.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Following a Serious Adverse Event (potential Hy's Law case), a risk-benefit assessment review of all preliminary safety data, and a review by Pfizer's internal hepatic injury advisory panel, it was concluded that PF-04287881 had an unacceptable therapeutic window. The FDA was notified of our intention to discontinue development as of 09April2010.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 must 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 hypersensitivity 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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Drug: PF-04287881
500 mg once daily for 10 days
Drug: Placebo
To match 500 mg dose once daily for 10 days
Drug: PF-04287881
750 mg once daily for 10 days
Drug: Placebo
To match 750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg once daily for 10 days
Drug: Placebo
To match 1100 mg dose once daily for 10 days
Drug: PF-04287881
Optional cohort with dose not greater than 1100 mg
Drug: Placebo
Optional cohort to match dose not greater than 1100 mg
Drug: PF-04287881
750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg dose once daily for 10 days
Experimental: Cohort 2
Drug: PF-04287881
500 mg once daily for 10 days
Drug: Placebo
To match 500 mg dose once daily for 10 days
Drug: PF-04287881
750 mg once daily for 10 days
Drug: Placebo
To match 750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg once daily for 10 days
Drug: Placebo
To match 1100 mg dose once daily for 10 days
Drug: PF-04287881
Optional cohort with dose not greater than 1100 mg
Drug: Placebo
Optional cohort to match dose not greater than 1100 mg
Drug: PF-04287881
750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg dose once daily for 10 days
Experimental: Cohort 3
Drug: PF-04287881
500 mg once daily for 10 days
Drug: Placebo
To match 500 mg dose once daily for 10 days
Drug: PF-04287881
750 mg once daily for 10 days
Drug: Placebo
To match 750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg once daily for 10 days
Drug: Placebo
To match 1100 mg dose once daily for 10 days
Drug: PF-04287881
Optional cohort with dose not greater than 1100 mg
Drug: Placebo
Optional cohort to match dose not greater than 1100 mg
Drug: PF-04287881
750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg dose once daily for 10 days
Experimental: Cohort 4 (optional)
If intermediate or repeat dose level is needed; dose will not exceed 1100 mg.
Drug: PF-04287881
500 mg once daily for 10 days
Drug: Placebo
To match 500 mg dose once daily for 10 days
Drug: PF-04287881
750 mg once daily for 10 days
Drug: Placebo
To match 750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg once daily for 10 days
Drug: Placebo
To match 1100 mg dose once daily for 10 days
Drug: PF-04287881
Optional cohort with dose not greater than 1100 mg
Drug: Placebo
Optional cohort to match dose not greater than 1100 mg
Drug: PF-04287881
750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg dose once daily for 10 days
Experimental: Cohort 5 (Japanese)
Drug: PF-04287881
500 mg once daily for 10 days
Drug: Placebo
To match 500 mg dose once daily for 10 days
Drug: PF-04287881
750 mg once daily for 10 days
Drug: Placebo
To match 750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg once daily for 10 days
Drug: Placebo
To match 1100 mg dose once daily for 10 days
Drug: PF-04287881
Optional cohort with dose not greater than 1100 mg
Drug: Placebo
Optional cohort to match dose not greater than 1100 mg
Drug: PF-04287881
750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg dose once daily for 10 days
Experimental: Cohort 6 (Japanese)
Drug: PF-04287881
500 mg once daily for 10 days
Drug: Placebo
To match 500 mg dose once daily for 10 days
Drug: PF-04287881
750 mg once daily for 10 days
Drug: Placebo
To match 750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg once daily for 10 days
Drug: Placebo
To match 1100 mg dose once daily for 10 days
Drug: PF-04287881
Optional cohort with dose not greater than 1100 mg
Drug: Placebo
Optional cohort to match dose not greater than 1100 mg
Drug: PF-04287881
750 mg dose once daily for 10 days
Drug: PF-04287881
1100 mg dose once daily for 10 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Standard safety assessments including assessment of AEs, laboratory tests, ECGs, and vital signs.
Time Frame: Screening, Dosing days 1-10, through follow-up
Screening, Dosing days 1-10, through follow-up
The primary pharmacokinetic endpoints to be evaluated for PF-04287881 include Cmax, Tmax, and AUC(0-24) on Day 1 and Day 10.
Time Frame: Day 1 and 10
Day 1 and 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Secondary parameters include AUCinf and t1/2 as data permit, apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) and accumulation ratio (Rac).
Time Frame: Days 1, 5 and 10
Days 1, 5 and 10
Urine concentrations of PF 04287881 in Cohorts 2 and 5 will be used to determine total amount excreted (Ae), %Ae relative to dose given and renal clearance (CLR).
Time Frame: Day 10
Day 10
Concentrations of PF 04287881 will be measured in white blood cell (WBC) polymorphonuclear cells (PMNs) in Cohorts 2 and 5 to determine total exposure in WBC.
Time Frame: Days 1 and 10
Days 1 and 10
Plasma samples from Cohort 2 will be used for exploratory investigation of circulating metabolites.
Time Frame: Days 1 and 10
Days 1 and 10

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B0581002

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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