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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: SB-656933-AAA
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving treatment sequence 1<br>Eligible subjects will receive single doses of placebo in period 1, SB-656933-AAA with a dose of 50 milligrams in period 2 and 150 milligrams in period 3. | Drug: SB-656933-AAA<br>* SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.<br>Drug: Placebo<br>* Placebo tablets will be intended to be administered orally.<br>|
| Experimental: Subjects receiving treatment sequence 2<br>Eligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, placebo in period 2 and SB-656933-AAA 150 milligrams in period 3. | Drug: SB-656933-AAA<br>* SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.<br>Drug: Placebo<br>* Placebo tablets will be intended to be administered orally.<br>|
| Experimental: Subjects receiving treatment sequence 3<br>Eligible subjects will receive single doses of SB-656933-AAA with a dose of 50 milligrams in period 1, 150 milligrams in period 2 and placebo in period 3. | Drug: SB-656933-AAA<br>* SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.<br>Drug: Placebo<br>* Placebo tablets will be intended to be administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SB-656933-AAA,, ozone challenge, single dose,