Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
NCT ID: NCT00551811
Last Updated: 2017-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
23 participants
INTERVENTIONAL
2007-10-08
2008-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Hepatitis B or C and/or HIV positive.
* Currently on regular medication except paracetamol.
* Body Mass Index \<20 or \>30.
18 Years
50 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Berlin, , Germany
Countries
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References
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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.
Other Identifiers
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CR2100597
Identifier Type: -
Identifier Source: org_study_id
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