PH-797804 LPS Study in Healthy Volunteers

Phase 1CompletedNCT02084485

Pfizer24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PH-797804DRUG

30 MG Single dose

PlaceboDRUG

matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Denmark Hill, London, United Kingdom

Outcomes

Primary Outcomes

Sputum Cell Counts

Neutrophil \& Macrophage count (total and differential)

Time frame: 6 hours post LPS challenge

Sputum Cytokines

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

Time frame: 6 hours post LPS challenge

Secondary Outcomes

Systemic Inflammatory Indices

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

Time frame: 1, 4, 6 and 7 hours post LPS

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.