NCT01314885

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

11 months

First QC Date

November 5, 2010

Last Update Submit

February 1, 2012

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • Change from baseline in ECG parameters

    Baseline, Day 1 and Day 2

  • Change from baseline in BP parameters

    Baseline, Day 1 and Day 2

  • +1 more secondary outcomes

Study Arms (4)

PF-03715455

EXPERIMENTAL
Drug: PF-03715455

PH-797804

EXPERIMENTAL
Drug: PH-797804

Placebo for PF-03715455

PLACEBO COMPARATOR
Drug: Placebo for PF-03715455

Placebo for PH-797804

PLACEBO COMPARATOR
Drug: Placebo for PH-797804

Interventions

PF-03715455DRUG

20mg, Inhaled, single dose

PF-03715455
PH-797804DRUG

30mg, Oral, single dose

PH-797804
Placebo for PF-03715455DRUG

Single dose, inhaled, Placebo for PF-03715455

Placebo for PF-03715455
Placebo for PH-797804DRUG

Single Dose, Oral, Placebo for PH-797804

Placebo for PH-797804

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

London, SE1 1YR, United Kingdom

Location

Pfizer Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

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)-ureaPH 797804

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2010

First Posted

March 15, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations

GB(2)