Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone

GlaxoSmithKline23 enrolled

Overview

A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects who have been challenged with ozone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

SB-656933-AAADRUG

SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.

PlaceboDRUG

Placebo tablets will be intended to be administered orally.

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects between 18-50 years. * Females should be of non-child bearing potential. * Non-smoking for at least 12 months. * Normal lung function. * Subjects should be able to produce acceptable sputum samples. Exclusion Criteria: * Any serious medical condition. * Hepatitis B or C and/or HIV positive. * Currently on regular medication except paracetamol. * Body Mass Index \<20 or \>30.

Locations (1)

GSK Investigational Site

Berlin, Germany

Outcomes

Primary Outcomes

To assess the effect of a single dose of SB-656933-AAA on ozone-induced inflammation in healthy subjects. Total number of neutrophils in sputum 6 hours after inhaling ozone.

Time frame: 6 hours after inhaling ozone

Secondary Outcomes

Total number of white cells in sputum 6 hours after inhaling ozone. Concentration of protein in sputum. Safety of SB-656933-AAA.

Time frame: 6 hours after inhaling ozone

Data from ClinicalTrials.gov

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