PH-797804 LPS Study in Healthy Volunteers

March 13, 2014 updated by: Pfizer

A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Determine the Effects of a Single Oral Dose of Ph-797804 on Induced Sputum Inflammatory Markers Following Inhaled Lipopolysaccharide (Lps) Challenge in Healthy Volunteers

The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for patients with Chronic Obstructive Pulmonary Disease (COPD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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 Kingdom
    • London
      • Denmark Hill, London, United Kingdom, SE5 9PJ
        • 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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female (WONCBP), non atopic volunteers aged 18-50 years
  • Able to produce sputum

Exclusion Criteria:

  • Current Smokers
  • Abnormal liver function test
  • Respiratory Tract Infection within 4 weeks

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Drug: PH-797804
30 MG Single dose
Placebo Comparator: Arm B
Drug: Placebo
matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sputum Cell Counts
Time Frame: 6 hours post LPS challenge
Neutrophil & Macrophage count (total and differential)
6 hours post LPS challenge
Sputum Cytokines
Time Frame: 6 hours post LPS challenge
TNF-α, MIP-1β, IL-6, MPO, MCP-1, GRO-α
6 hours post LPS challenge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systemic Inflammatory Indices
Time Frame: 1, 4, 6 and 7 hours post LPS
Neutrophil count, GRO-α, TNF-α, MIP-1β, IL-6, MPO, MCP-1, CRP
1, 4, 6 and 7 hours post LPS

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

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

September 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 9, 2014

First Posted (Estimate)

March 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A6631010

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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