Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Effects Of Single Inhaled Doses Of PF-03715455 (20 Mg) And PH-797804 (30 Mg) On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01314885

Enrollment

Registered

2011-03-15

Start date

2011-01-31

Completion date

2011-12-31

Last updated

2012-02-02

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Healthy

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

Interventions

DRUGPF-03715455

20mg, Inhaled, single dose

DRUGPH-797804

30mg, Oral, single dose

DRUGPlacebo for PF-03715455

Single dose, inhaled, Placebo for PF-03715455

DRUGPlacebo for PH-797804

Single Dose, Oral, Placebo for PH-797804

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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
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
Change from baseline in ECG parameters	Baseline, Day 1 and Day 2

Countries

United Kingdom

Outcome results

None listed

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