Last updated: 11/04/2018 08:15:05

Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males

GSK study ID
HTP103265
Clinicaltrials.gov ID
NCT00435695
EudraCT ID
Not applicable
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, non-randomized positron emission tomography study in healthy male subjects to investigate brain 5-HT1A receptor occupancy, pharmacokinetics and safety of single oral doses of GSK163090, using the ligand [11C]-WAY100635.
Trial description: The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. This study will use a medical imaging technique called Positron Emission Tomography (PET) which uses an imaging agent called [11C]-WAY100635.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090

Timeframe: throughout the study

Secondary outcomes:

Vitals signs ECGs Clinical Laboratory test results

Timeframe: throughout the study

Interventions:
  • Drug: GSK163090
    • Enrollment:
    13
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects, Depressive Disorder and Anxiety Disorders
    Product
    GSK163090
    Collaborators
    Not applicable
    Study date(s)
    November 2006 to December 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Healthy male subjects, aged 18-45 years Body weight > 50 kg
    • Non-Smoker
    • History of any cardiac disease
    • History of regular alcohol consumption averaging >14 drinks/week
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy male subjects, aged 18-45 years Body weight > 50 kg
    • Non-Smoker
    • Normal ECG, heart rate and blood pressure
    Exclusion criteria:
    • History of any cardiac disease
    • History of regular alcohol consumption averaging >14 drinks/week
    • Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts
    • Positive for Hepatitis B and C, and HIV.
    • History of drug abuse.
    • Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
    • Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
    • Suffers from claustrophobia
    • History or presence of neurological or psychiatric conditions
    • Presence of a cardiac pacemaker or other implanted electronic device or metal implants

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M5T 1R8
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-06-12

    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

    Additional information
    Not applicable
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