NCT02084485

Brief Summary

The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for patients with Chronic Obstructive Pulmonary Disease (COPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
Last Updated

March 14, 2014

Status Verified

March 1, 2014

Enrollment Period

1.5 years

First QC Date

March 3, 2014

Last Update Submit

March 13, 2014

Conditions

Healthy

Keywords

COPDLPS

Outcome Measures

Primary Outcomes (2)

  • Sputum Cell Counts

    Neutrophil \& Macrophage count (total and differential)

    6 hours post LPS challenge

  • Sputum Cytokines

    TNF-α, MIP-1β, IL-6, MPO, MCP-1, GRO-α

    6 hours post LPS challenge

Secondary Outcomes (1)

  • Systemic Inflammatory Indices

    1, 4, 6 and 7 hours post LPS

Study Arms (2)

Arm A

EXPERIMENTAL
Drug: PH-797804

Arm B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PH-797804DRUG

30 MG Single dose

Arm A
PlaceboDRUG

matching placebo

Arm B

Eligibility Criteria

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

You may qualify if:

  • Healthy male or female (WONCBP), non atopic volunteers aged 18-50 years
  • Able to produce sputum

You may not qualify if:

  • Current Smokers
  • Abnormal liver function test
  • Respiratory Tract Infection within 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Denmark Hill, London, SE5 9PJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

PH 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
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 12, 2014

Study Start

September 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 14, 2014

Record last verified: 2014-03

Locations

GB(1)