Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Proof of Mechanism

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-03715455

Group Type EXPERIMENTAL

PF-03715455

Intervention Type DRUG

20mg, Inhaled, single dose

PH-797804

Group Type EXPERIMENTAL

PH-797804

Intervention Type DRUG

30mg, Oral, single dose

Placebo for PF-03715455

Group Type PLACEBO_COMPARATOR

Placebo for PF-03715455

Intervention Type DRUG

Single dose, inhaled, Placebo for PF-03715455

Placebo for PH-797804

Group Type PLACEBO_COMPARATOR

Placebo for PH-797804

Intervention Type DRUG

Single Dose, Oral, Placebo for PH-797804

Interventions

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PF-03715455

20mg, Inhaled, single dose

Intervention Type DRUG

PH-797804

30mg, Oral, single dose

Intervention Type DRUG

Placebo for PF-03715455

Single dose, inhaled, Placebo for PF-03715455

Intervention Type DRUG

Placebo for PH-797804

Single Dose, Oral, Placebo for PH-797804

Intervention Type DRUG

Eligibility Criteria

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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 able to successfully complete screening sputum inductions.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes