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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00551811

First Posted: October 31, 2007

Last Update Posted: August 7, 2017

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.

Information provided by (Responsible Party):

GlaxoSmithKline

Purpose

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	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: SB-656933-AAA Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Ozone

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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:

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 ]


Enrollment:	23
Actual Study Start Date:	October 8, 2007
Study Completion Date:	July 22, 2008
Primary Completion Date:	July 22, 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

Locations


Germany
GSK Investigational Site
Berlin, Germany, 14050

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

Results for study CR2100597 can be found on the GSK Clinical Study Register. This link exits the ClinicalTrials.gov site

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 Submitted:	October 29, 2007
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

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