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

GSK study ID
CR2100597
See study documents
Clinicaltrials.gov ID
NCT00551811
EudraCT ID
2004-002874-48
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    Not applicable
    Observational study model:
    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)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14050
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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

    Participate in clinical trial
    Additional information
    Results for study CR2100597 can be found on the GSK Clinical Study Register.
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