PH-797804 LPS Study in Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02084485

Enrollment

Registered

2014-03-12

Start date

2006-09-30

Completion date

2008-03-31

Last updated

2014-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

COPD, LPS

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).

Interventions

DRUGPH-797804

30 MG Single dose

DRUGPlacebo

matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026