PH-797804 LPS Study in Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PH-797804; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02084485

A6631010

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Arm A

Experimental group

Treatment:

Drug: PH-797804

Arm B

Placebo Comparator group

Treatment:

Drug: Placebo