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PF-03715455

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |Pfizer, Inc.|Trials Updated: Feb 2, 2012

PF-03715455 development status

Highest phase Phase 2 (NCT02366637)
Phase scored for PFEPhase 1
Registered trials 4 across 1 sponsor since Aug 2010

PF-03715455 target and mechanism

Molecular targetMAPK14
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

PF-03715455 clinical trials

PF-03715455 · 1 trial · 1 indication

Phase 1 1
NCT01314885Single Dose Lipopolysaccharide (LPS) Study In Healthy VolunteersChronic Obstructive Pulmonary Disease (COPD)
COMPLETED39 Analytics
PHASE1COMPLETED
Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
PF-03715455EXPERIMENTAL -
PH-797804EXPERIMENTAL -
Placebo for PF-03715455PLACEBO_COMPARATOR -
Placebo for PH-797804PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-03715455DRUG20mg, Inhaled, single dose
PH-797804DRUG30mg, Oral, single dose
Placebo for PF-03715455DRUGSingle dose, inhaled, Placebo for PF-03715455
Placebo for PH-797804DRUGSingle Dose, Oral, Placebo for PH-797804
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 ...

Countries:United Kingdom
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Frequently asked questions about PF-03715455

What is PF-03715455?

PF-03715455 is an investigational small molecule drug that Pfizer, Inc. (ticker PFE) developed for Chronic Obstructive Pulmonary Disease (COPD), a respiratory condition. It was studied in a Phase 1 clinical trial and is not an approved medicine. Development reached the early clinical stage only.

What is PF-03715455 used for in COPD?

PF-03715455 was being developed for Chronic Obstructive Pulmonary Disease (COPD), a respiratory condition. Its only recorded clinical study enrolled healthy adult volunteers rather than COPD patients, and it was designed as a single dose study. The drug is investigational and is not approved for treating COPD or any other condition.

What does PF-03715455 target?

PF-03715455 targets MAPK14, also known as p38 alpha, and acts as an inhibitor of that enzyme. MAPK14 is a kinase involved in inflammatory signaling pathways. Inhibiting MAPK14 was the intended mechanism for addressing the inflammatory component of Chronic Obstructive Pulmonary Disease (COPD).

Who makes PF-03715455?

PF-03715455 was developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the compound's clinical program in respiratory disease. The asset is an internal Pfizer small molecule and reached Phase 1 testing before the program's recorded study was completed.

What phase is PF-03715455 in?

PF-03715455 reached Phase 1 clinical development. It is an investigational drug and is not FDA approved. Its single recorded trial, NCT01314885, is completed, and no active trials are listed for the compound. The program therefore sits at the earliest stage of human testing.

What clinical trials is PF-03715455 in?

PF-03715455 was studied in one clinical trial, NCT01314885, titled Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers. The Phase 1 trial was completed, enrolled 39 healthy adult participants in the United Kingdom, and used a randomized, double-blind, placebo-controlled design. No other trials of PF-03715455 are recorded.