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

A Dose Ranging Study to Assess the Effect of Pre-treatment With a Single Dose of Oral SB656933 on Lung Inflammation Following Challenge With Inhaled Ozone and Intermittent Exercise in Healthy Volunteers, Relative to Placebo

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00551811

Enrollment

Registered

2007-10-31

Start date

2007-10-08

Completion date

2008-07-22

Last updated

2017-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

SB-656933-AAA,, ozone challenge, single dose,

Brief summary

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.

Interventions

DRUGSB-656933-AAA

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

DRUGPlacebo

Placebo tablets will be intended to be administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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.	6 hours after inhaling ozone

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026