Last updated: 11/04/2018 05:52:03

An Imaging Study to investigate the distribution of GW842166X in the brain.

GSK study ID
CBA103679
See study documents
Clinicaltrials.gov ID
NCT00511524
EudraCT ID
2006-006351-12
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: An open label positron emission tomography (PET) study to investigate brain penetration by [11C]GW842166 in healthy subjects
Trial description: GW842166X is being developed for the treatment and management of inflammatory pain. GW842166X is a CB2 receptor agonist and the mechanism is not fully understood, although it is thought that for the anti-inflammatory action the drug is required to cross inot the brain from the blood. This study aims to look at if the drug crosses into the brain once given orally using an imaging technique called positron emission tomography.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Rate at which the drug crosses from plasma to brain (ki)using images from the scan

Timeframe: throughout the study

Secondary outcomes:

Safety of drug

Timeframe: after taking the drug pre-dose, 2hr, 4hr, 6hr, 10hr, 24hr, follow-up.

Interventions:
  • Drug: GW842166X
  • Drug: [carbonyl-^11C]GW842166
    • Enrollment:
    6
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Pain, Inflammatory
    Product
    GW842166
    Collaborators
    Not applicable
    Study date(s)
    June 2007 to July 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    50 - 80 years
    Accepts healthy volunteers
    Yes
    • Male aged 50 to 80yrs inclusive at the screening visit.
    • subjects with negative HIV and hepatitis B and C test results within 3 months of study start.
    • A negative Allens test on arm to be used for arterial cannulation.
    • Any contraindications to MRI scanning.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male aged 50 to 80yrs inclusive at the screening visit.
    • subjects with negative HIV and hepatitis B and C test results within 3 months of study start.
    Exclusion criteria:
    • A negative Allens test on arm to be used for arterial cannulation.
    • Any contraindications to MRI scanning.
    • History or presence of hepatic or renal disease.
    • Previous involvement in PET or radiological investigations.
    • Family history of cancer.
    • History of claustrophobia
    • Presence of a cardiac pacemaker or any other electronic device or ferromagnetic metal

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    UPPSALA, Sweden, SE-753 23
    Status
    Will Be Recruiting
    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
    2007-04-07

    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 CBA103679 can be found on the GSK Clinical Study Register.
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