Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

Phase 1

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: PF-03715455; Drug: Placebo for PF-03715455; Drug: Placebo for PH-797804; Drug: PH-797804

• Registration Number: NCT01314885
• Lead Sponsor: Pfizer

Brief Summary

A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study.

Detailed Description

Proof of Mechanism

Study Timeline

• Study First Submitted: 2010-11-05
• Study Start: 2011-01
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Male or female (of non-child bearing potential) subjects, aged 18-50 years.
• Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height.
• Subjects who have normoresponsive airways.
• Subjects who are able to successfully complete screening sputum inductions.

Exclusion Criteria

• Subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. Specifically liver function tests and CRP must be within the reference range.
• Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest).
• Subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-03715455	PF-03715455	-
Placebo for PF-03715455	Placebo for PF-03715455	-
Placebo for PH-797804	Placebo for PH-797804	-
PH-797804	PH-797804	-

Primary Outcome Measures

Name	Time	Method
Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint	6 hours

Secondary Outcome Measures

Name	Time	Method
Cell counts, IL-6, MPO, MCP-1, MIP1b are individual endpoints which will be evaluated in sputum however they are collected as a single sample.	6 hours
Post-LPS systemic inflammatory indices: Neutrophil count, IL-6, IL-10, MPO, MCP-1, MIP1b, fibrinogen, CC16 and CRP. These are individual endpoints which will be evaluated in blood however they are collected as a single sample.	1, 4, 6 and 7 hours
Number of participants with adverse events	Baseline, Day 1 and Day 2
Change from baseline in ECG parameters	Baseline, Day 1 and Day 2
Change from baseline in BP parameters	Baseline, Day 1 and Day 2
Change from baseline in lab safety parameters	Baseline, Day 1 and Day 2

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Manchester, United Kingdom