Endotoxin Challenge Study For Healthy Men and Women

GlaxoSmithKline37 enrolled

Overview

The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK256066DRUG

GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.

PlaceboDRUG

Subjects will receive placebo inhaler.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy males and females (contraception restrictions), * 18-50yrs, * BMI 19-31kg/m2, * Non-smokers, * FEV1 \>/= 80% predicted Exclusion Criteria: * Abnormal troponin and/or CK MB, * Participated in any GSK study involving the administration of COA for \>/= 21 days.

Locations (1)

GSK Investigational Site

Hanover, Lower Saxony, Germany

Outcomes

Primary Outcomes

Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure

Time frame: 24 hours

Secondary Outcomes

Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8

Time frame: Day 1,Day 7&DAY 8

Data from ClinicalTrials.gov

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