Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00551811 |
Recruitment Status :
Completed
First Posted : October 31, 2007
Last Update Posted : August 7, 2017
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Disease, Chronic Obstructive | Drug: SB-656933-AAA Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | October 8, 2007 |
Actual Primary Completion Date : | July 22, 2008 |
Actual Study Completion Date : | July 22, 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: Subjects receiving treatment sequence 1
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.
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Drug: SB-656933-AAA
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally. Drug: Placebo Placebo tablets will be intended to be administered orally. |
Experimental: Subjects receiving treatment sequence 2
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.
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Drug: SB-656933-AAA
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally. Drug: Placebo Placebo tablets will be intended to be administered orally. |
Experimental: Subjects receiving treatment sequence 3
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.
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Drug: SB-656933-AAA
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally. Drug: Placebo Placebo tablets will be intended to be administered orally. |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551811
Germany | |
GSK Investigational Site | |
Berlin, Germany, 14050 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00551811 |
Other Study ID Numbers: |
CR2100597 |
First Posted: | October 31, 2007 Key Record Dates |
Last Update Posted: | August 7, 2017 |
Last Verified: | August 2017 |
SB-656933-AAA, ozone challenge single dose, |
Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |