Last updated: 11/07/2018 02:45:46

Positron Emission Tomography (PET) study to describe the relationship between plasma concentrations and brain Gly-T1 occupancy of GSK1018921 over time.

Request patient level data
GSK study ID
109731
See study documents
Clinicaltrials.gov ID
NCT00945503
EudraCT ID
2007-007163-24
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 adaptive PET study in healthy volunteers using [11C]GSK931145 to establish the relationship of Glycine Transporter 1 occupancy by GSK1018921 to plasma concentrations over time.
Trial description: A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

PET occupancy with GSK1018921

Timeframe: 10 days

Secondary outcomes:

To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests.

Timeframe: 10 days

Interventions:
  • Drug: GSK1018921
    • Enrollment:
    12
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Roger Gunn, Venkatesha Murthy, Anna Catafau, Graham Searle, Santiago Bullich, Mark Slifstein, Danielle Ouellet, Stefano Zamuner, Raul Herance, Cristian Salinas, Ricardo Pardo-Lozano, Eugenii Rabiner, Magi Farre, Marc Laruelle. Translational Characterization of 11CGSK931145, a PET Ligand for the Glycine Transporter Type 1 (GlyT-1).. Synapse. 2011;65(12):1319-1332.
    Medical condition
    Schizophrenia
    Product
    GSK1018921
    Collaborators
    Not applicable
    Study date(s)
    May 2008 to December 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy male subjects
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion criteria: -Healthy male subjects -Age: 18-55 years -No history of physical, neurological or mental illness

      • Exclusion criteria -History of claustrophobia or inability to lie still in the PET camera for at least 2 hours -Cardiac pacemakers or metal implants in the body that contraindicate MRI scan. -History of regular alcohol consumption (weekly intake >21 units) within the previous six months.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Barcelona, Spain
    Status
    Study Complete
    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
    2008-22-12

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Results for study 109731 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website