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Completed

NCT Number: NCT02084485

PH-797804 LPS Study 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).

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Key information

Conditions

Healthy Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Denmark Hill, London, SE5 9PJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

PH-797804

Drug

30 MG Single dose

Placebo

Drug

matching placebo

Primary outcomes

  1. Sputum Cell Counts

    Time frame: 6 hours post LPS challenge

    Neutrophil & Macrophage count (total and differential)

  2. Sputum Cytokines

    Time frame: 6 hours post LPS challenge

    TNF-α, MIP-1β, IL-6, MPO, MCP-1, GRO-α

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2014
Registry last updated
Mar 14, 2014

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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