Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
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
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2007
CompletedFirst Submitted
Initial submission to the registry
October 29, 2007
CompletedFirst Posted
Study publicly available on registry
October 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2008
CompletedAugust 7, 2017
August 1, 2017
10 months
October 29, 2007
August 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
6 hours after inhaling ozone
Secondary Outcomes (1)
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
Study Arms (3)
Subjects receiving treatment sequence 1
EXPERIMENTALEligible 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.
Subjects receiving treatment sequence 2
EXPERIMENTALEligible 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.
Subjects receiving treatment sequence 3
EXPERIMENTALEligible 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.
Interventions
SB-656933-AAA tablets will be available with a dose strength of 50 milligrams, administered orally.
Placebo tablets will be intended to be administered orally.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
- Currently on regular medication except paracetamol.
- Body Mass Index \<20 or \>30.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Berlin, 14050, Germany
Related 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.
PMID: 21426372BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2007
First Posted
October 31, 2007
Study Start
October 8, 2007
Primary Completion
July 22, 2008
Study Completion
July 22, 2008
Last Updated
August 7, 2017
Record last verified: 2017-08