Last updated: 11/04/2018 08:24:53

Endotoxin Challenge Study For Healthy Men and Women

GSK study ID
IPC103711
See study documents
Clinicaltrials.gov ID
NCT00515268
EudraCT ID
2007-001935-75
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 double blind, placebo controlled, repeat dose study to compare the effectiveness of two doses of GSK256066 with placebo in reducing lung inflammation following segmental LPS challenge in healthy volunteers
Trial description: The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure

Timeframe: 24 hours

Secondary outcomes:

Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8

Timeframe: Day 1,Day 7&DAY 8

Interventions:
  • Drug: GSK256066
  • Drug: Placebo
    • Enrollment:
    37
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    GSK256066
    Collaborators
    Not applicable
    Study date(s)
    September 2007 to April 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 50 years
    Accepts healthy volunteers
    Yes
    • Healthy males and females (contraception restrictions),
    • 18-50yrs,
    • Abnormal troponin and/or CK MB,
    • Participated in any GSK study involving the administration of COA for >/= 21 days.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy males and females (contraception restrictions),
    • 18-50yrs,
    • BMI 19-31kg/m2,
    • Non-smokers,
    • FEV1 >/= 80% predicted
    Exclusion criteria:
    • Abnormal troponin and/or CK MB,
    • Participated in any GSK study involving the administration of COA for >/= 21 days.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30625
    Status
    Will Be Recruiting
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2008-23-04

    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 IPC103711 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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