Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

Pfizer

Status and phase

Completed

Phase 1

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Placebo for PH-797804

Drug: PF-03715455

Drug: PH-797804

Drug: Placebo for PF-03715455

Study type

Interventional

Funder types

Industry

Identifiers

NCT01314885

A9111003

Details and patient eligibility

About

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.

Full description

Proof of Mechanism

Enrollment

39 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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