Last updated: 11/07/2018 03:04:12

Brain uptake of GSK1034702: a Positron Emission Tomography (PET) scan study

Request patient level data
GSK study ID
110771
See study documents
Clinicaltrials.gov ID
NCT00937846
EudraCT ID
2008-007450-35
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 [carbonyl-11C] GSK1034702 in healthy subjects
Trial description: GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate how much of the study drug gets into the brain. This will be done using Positron Emission Tomography (PET).
Primary purpose:
Supportive Care
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Volume of distribution of [11C]GSK1034702 at tracer and pharmacological doses.

Timeframe: Scanning day

Secondary outcomes:

The kinetic rate constants at tracer and pharmacological doses.

Timeframe: Scanning day

GSK1034702 PK parameters: Cmax; tmax; AUC(0-t).

Timeframe: Scanning day

Safety and tolerability endpoints consisting of: AEs; 12-lead ECG; 12 lead digital Holter and lead II telemetry; vital signs; clinical laboratory evaluations.

Timeframe: 2 weeks

Interventions:
  • Drug: GSK1034702
    • Enrollment:
    4
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Khanum Ridler, Vincent Cunningham, Mickael Huiban, Laurent Martarello, Sabina Pampols-Maso, Jan Passchier, Roger N. Gunn, Graham Searle, Anissa Abi-Dargham, Mark Slifstein, Jeanette Watson, Marc Laruelle, and Eugenii A. Rabiner. An evaluation of the brain distribution of [11C]GSK1034702, a Muscarinic-1 (M1) positive allosteric modulator in the living human brain using positron emission tomography. EJNMMI Res. 2014;4(66):
    Medical condition
    Cognitive Disorders
    Product
    GSK1034702
    Collaborators
    Not applicable
    Study date(s)
    July 2009 to August 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    35 - 55 years
    Accepts healthy volunteers
    Yes
    • Generally healthy.
    • Male between 35 and 55 years of age.
    • Abuse of drugs or alcohol.
    • Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Generally healthy.
    • Male between 35 and 55 years of age.
    • Willing to use appropriate contraception method.
    • Weight more than 50 kg.
    • BMI within the range 19
    • 29 kg/m2.
    • Adequate blood supply to the hand.
    Exclusion criteria:
    • Abuse of drugs or alcohol.
    • Smoker or history of regular use of tobacco- or nicotine-containing products in the past 6 months.
    • ECG abnormality (personal or family history).
    • Psychiatric disorder.
    • Asthma or a history of asthma.
    • Medical illness.
    • Worked as a welder, metal worker or machinist.
    • Suffers from claustrophobia or would be unable to lie still in a PET or MRI scanner for 1-2 hours.
    • Has a cardiac pacemaker or other electrical device or ferromagnetic metal foreign bodies.
    • Neurological disorder

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, NW10 7EW
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    London, London, United Kingdom, W12 ONN
    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
    2009-28-08

    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 110771 can be found on the GSK Clinical Study Register.
    Click here
    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
    Access to clinical trial data by researchers
    Visit website