Last updated: 11/04/2018 05:59:50
Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: 6 hours after inhaling ozone
Secondary outcomes:
Total number of white cells in sputum 6 hours after inhaling ozone. Concentration of protein in sputum. Safety of SB-656933-AAA.
Timeframe: 6 hours after inhaling ozone
Interventions:
Drug: SB-656933-AAA
Drug: Placebo
Enrollment:
23
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Aili L. Lazaar, Lisa E. Sweeney, Alexander J. MacDonald, Neil E. Alexis, Chao Chen, Ruth Tal-Singer. SB-656933, a novel CXCR2 selective antagonist, inhibits ex-vivo neutrophil activation and ozone-induced airway inflammation in humans. [Br J Clin Pharmacol].
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
elubrixin
Collaborators
Not applicable
Study date(s)
October 2007 to July 2008
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- Healthy subjects between 18-50 years.
- Females should be of non-child bearing potential.
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2008-22-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study CR2100597 can be found on the GSK Clinical Study Register.
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