PH-797804 LPS Study in Healthy Volunteers

NCT ID: NCT02084485

Last Updated: 2014-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-03-31

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

30 MG Single dose

Arm B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

Interventions

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PH-797804

30 MG Single dose

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Current Smokers
* Abnormal liver function test
* Respiratory Tract Infection within 4 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Denmark Hill, London, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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A6631010

Identifier Type: -

Identifier Source: org_study_id

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