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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-03715455 | Experimental |
| |
| PH-797804 | Experimental |
| |
| Placebo for PF-03715455 | Placebo Comparator |
| |
| Placebo for PH-797804 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03715455 | Drug | 20mg, Inhaled, single dose |
| |
| PH-797804 |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | London | SE1 1YR | United Kingdom | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C569762 | N-(1-(3-chloro-4-hydroxyphenyl)-3-(1,1-dimethylethyl)-1H-pyrazol-5-yl)-N'-((2-((3-(2-((2-hydroxyethyl)thio)phenyl)-1,2,4-triazolo(4,3-a)pyridin-6-yl)thio)phenyl)methyl)-urea |
| C542398 | PH 797804 |
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| Drug |
30mg, Oral, single dose |
|
| Placebo for PF-03715455 | Drug | Single dose, inhaled, Placebo for PF-03715455 |
|
| Placebo for PH-797804 | Drug | Single Dose, Oral, Placebo for PH-797804 |
|
| 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 |
| Manchester |
| M23 9QZ |
| United Kingdom |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |