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NCT02084485 Clinical Trial

PH-797804 LPS Study in Healthy Volunteers

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02084485
Other study ID # A6631010
Secondary ID
Status Completed
Phase Phase 1
First received March 3, 2014
Last updated March 13, 2014
Start date September 2006
Est. completion date March 2008

Study information
Verified date March 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date March 2008
Est. primary completion date March 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• PH-797804
30 MG Single dose
• Placebo
matching placebo

Locations
Country Name City State
United Kingdom Pfizer Investigational Site Denmark Hill London

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sputum Cell Counts Neutrophil & Macrophage count (total and differential) 6 hours post LPS challenge No
Primary Sputum Cytokines TNF-a, MIP-1ß, IL-6, MPO, MCP-1, GRO-a 6 hours post LPS challenge
Secondary Systemic Inflammatory Indices Neutrophil count, GRO-a, TNF-a, MIP-1ß, IL-6, MPO, MCP-1, CRP 1, 4, 6 and 7 hours post LPS No
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