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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: SB-656933-AAA; Drug: Placebo	Phase 1

Study Design

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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

Arms and Interventions

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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.	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.	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.	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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

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Locations

Germany
GSK Investigational Site
Berlin, Germany, 14050

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Additional Information:

Results for study CR2100597 can be found on the GSK Clinical Study Register. 

Publications:

Lazaar AL, Sweeney LE, MacDonald AJ, Alexis NE, Chen C, Tal-Singer R. SB-656933, a novel CXCR2 selective antagonist, inhibits ex vivo neutrophil activation and ozone-induced airway inflammation in humans. Br J Clin Pharmacol. 2011 Aug;72(2):282-93. doi: 10.1111/j.1365-2125.2011.03968.x.

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00551811 History of Changes
Other Study ID Numbers:	CR2100597
First Posted:	October 31, 2007
Last Update Posted:	August 7, 2017
Last Verified:	August 2017

Keywords provided by GlaxoSmithKline:

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

Additional relevant MeSH terms:

Lung Diseases; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases	Disease Attributes; Pathologic Processes; Lung Diseases, Obstructive