PH-797804 LPS Study in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: PH-797804

• Registration Number: NCT02084485
• Lead Sponsor: Pfizer

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2014-03
• Study First Submitted: 2014-03-03
• Study First Submitted QC: 2014-03-09
• Study First Posted: 2014-03-12
• Last Update Submitted: 2014-03-13
• Last Update Posted: 2014-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm B	Placebo	-
Arm A	PH-797804	-

Primary Outcome Measures

Name	Time	Method
Sputum Cell Counts	6 hours post LPS challenge	Neutrophil \& Macrophage count (total and differential)
Sputum Cytokines	6 hours post LPS challenge	TNF-α, MIP-1β, IL-6, MPO, MCP-1, GRO-α

Secondary Outcome Measures

Name	Time	Method
Systemic Inflammatory Indices	1, 4, 6 and 7 hours post LPS	Neutrophil count, GRO-α, TNF-α, MIP-1β, IL-6, MPO, MCP-1, CRP

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Denmark Hill, London, United Kingdom