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.
Proof of Mechanism
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
39
20mg, Inhaled, single dose
30mg, Oral, single dose
Single dose, inhaled, Placebo for PF-03715455
Pfizer Investigational Site
London, United Kingdom
Pfizer Investigational Site
Manchester, United Kingdom
Post LPS sputum neutrophil % is being evaluated at the end of each treatment period to establish the effect of treatment on this endpoint
Time frame: 6 hours
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.
Time frame: 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.
Time frame: 1, 4, 6 and 7 hours
Number of participants with adverse events
Time frame: Baseline, Day 1 and Day 2
Change from baseline in ECG parameters
Time frame: Baseline, Day 1 and Day 2
Change from baseline in BP parameters
Time frame: Baseline, Day 1 and Day 2
Change from baseline in lab safety parameters
Time frame: Baseline, Day 1 and Day 2
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Single Dose, Oral, Placebo for PH-797804