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NCT00551811 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00551811
Other study ID # CR2100597
Secondary ID
Status Completed
Phase Phase 1
First received October 29, 2007
Last updated August 4, 2017
Start date October 8, 2007
Est. completion date July 22, 2008

Study information
Verified date August 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date July 22, 2008
Est. primary completion date July 22, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SB-656933-AAA
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.
• Placebo
Placebo tablets will be intended to be administered orally.

Locations
Country Name City State
Germany GSK Investigational Site Berlin

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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