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PF-03715455

Phase 1

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

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

Clinical trial landscape

PF-03715455 · 2 trials · 2 indications

Phase 1 2
NCT01314885Single Dose Lipopolysaccharide (LPS) Study In Healthy VolunteersChronic Obstructive Pulmonary Disease (COPD)
COMPLETED39 Analytics
NCT01186757Multiple Dose Healthy Volunteer Study of PF-03715455.Healthy Volunteers
COMPLETED36 Analytics
PHASE1COMPLETED
Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers
Chronic Obstructive Pulmonary Disease (COPD)
NCT0131488539
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PHASE1COMPLETED
Multiple Dose Healthy Volunteer Study of PF-03715455.
Healthy Volunteers
NCT0118675736
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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
Pharmacokinetics of single and multiple inhaled doses of PF-03715455, as measured by plasma concentrations - Cmax, Tmax, AUCtau, t½, accumulation ratio (Rac, Rss, Rac,Cmax).
17 days

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 -
PF-03715455 1.6mg BIDACTIVE_COMPARATOR -
PF-03715455 4 mg BIDACTIVE_COMPARATOR -
PF-03715455 10 mg BIDACTIVE_COMPARATOR -
PlaceboPLACEBO_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
PlaceboDRUGPlacebo
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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 KingdomSingapore
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Frequently asked questions about PF-03715455

What is PF-03715455?

PF-03715455 is an investigational small molecule being developed by Pfizer, Inc. (PFE) for respiratory conditions, including Chronic Obstructive Pulmonary Disease (COPD). It is currently in Phase 1 clinical development and has been studied in healthy volunteers. The drug is not yet approved and remains in clinical trials.

What is PF-03715455 used for?

PF-03715455 is being studied for use in Chronic Obstructive Pulmonary Disease (COPD) and in healthy volunteers for early-phase research. It is an investigational small molecule in Phase 1 development by Pfizer, Inc. (PFE). Its potential role in COPD is being evaluated in clinical trials, but it is not yet approved for any use.

Who makes PF-03715455?

PF-03715455 is being developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker PFE. The drug is an investigational small molecule in Phase 1 clinical development for respiratory conditions, including Chronic Obstructive Pulmonary Disease (COPD).

What phase is PF-03715455 in?

PF-03715455 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in healthy volunteers and one in participants with Chronic Obstructive Pulmonary Disease (COPD). The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-03715455 in?

PF-03715455 has completed two Phase 1 clinical trials: NCT01186757, a multiple-dose healthy volunteer study in Singapore, and NCT01314885, a single-dose lipopolysaccharide (LPS) study in healthy volunteers in the United Kingdom. Both trials are completed, with a total enrollment of 39 participants.

Is PF-03715455 the same as any other drug?

No alternative names for PF-03715455 have been disclosed. The drug is identified solely by its code name PF-03715455 in clinical trials and development records. It is an investigational small molecule being developed by Pfizer, Inc. (PFE) for respiratory conditions.