Last updated: 11/07/2018 02:55:31

An open label positron emission tomography (PET) study of GSK618334 in healthy male subjects using 11C-PHNO as PET ligand

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GSK study ID
110269
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Clinicaltrials.gov ID
NCT00814957
EudraCT ID
2008-001005-42
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 study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand.
Trial description: The purpose of this study is to investigate the relationship between the plasma concentrations of the study drug and the amount of the study drug bound to the D3 receptors of the brain after dosing of a new compound GSK618334.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Binding of PHNO, PET ligand, in each region of interest at each scan.

Timeframe: up to 48 hours

Percentage of PHNO, PET ligand, occupancy in each region of interest after a single oral dose of GSK618334 for each individual.

Timeframe: up to 48 hours

Time course of GSK618334 concentration in blood following a single oral dose.

Timeframe: up to 48 hours

Secondary outcomes:

Adverse events and other safety assessments such as clinically relevant changes in electrocardiography (ECG); vital signs (blood pressure, heart rate); laboratory safety data and physical examination.

Timeframe: screening to follow-up

Measuring GSK618334 in the body (pharmacokinetic endpoints): PK parameters of GSK618334 Cmax, AUCinf, tmax.

Timeframe: up to 48 hours

Interventions:
  • Drug: GSK618334
    • Enrollment:
    12
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Substance Dependence
    Product
    GSK618334
    Collaborators
    Not applicable
    Study date(s)
    December 2008 to June 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    30 - 55 years
    Accepts healthy volunteers
    Yes
    • healthy, male subjects aged between 30 and 55 old inclusive.
    • normal body weight.
    • smoker or uses other nicotine-containing products.
    • certain medical conditions including heart disease, neurological disease, gastrointestinal disease, kidney or liver dysfunction - abnormal laboratory tests.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • healthy, male subjects aged between 30 and 55 old inclusive.
    • normal body weight.
    • normal ECG and vital signs.
    • agree to use acceptable contraceptive methods required.
    • capable of giving written informed consent.
    Exclusion criteria:
    • smoker or uses other nicotine-containing products.
    • certain medical conditions including heart disease, neurological disease, gastrointestinal disease, kidney or liver dysfunction
    • abnormal laboratory tests.
    • certain psychiatric conditions and use of certain psychoactive drugs .
    • positive blood alcohol or urine drug test.
    • alcohol intake over 14 drinks per week.
    • participation in another drug trial within 30 days or a study involving significant radiation exposure.
    • donation of more than 450 mL blood within the 56 days.
    • family history of cancer (one or more first-degree relative diagnosed before the age of 55 years old).
    • having cardiac pacemaker or other electronic device.
    • suffers from claustrophobia or feels that he will be unable to lie still on his back in the PET camera.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Harrow, Middlesex, United Kingdom, HA1 3UJ
    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
    2009-11-06

    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

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    Additional information
    Results for study 110269 can be found on the GSK Clinical Study Register.
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