Last updated: 11/04/2018 07:59:55

First Time in Human Study with GSK1018921

GSK study ID
GT1109727
See study documents
Clinicaltrials.gov ID
NCT00527020
EudraCT ID
2007-001792-11
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: Single-Blind, randomised, placebo-controlled first time in human study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of single oral escalating doses of GSK1018921 in healty volunteers and a randomized, double-blind, double dummy, placebo controlled, three-way crossover study in a separate cohort of healthy volunteers to test the effect of single doses of GSK1018921 and nicotine on qEEG and MMN in healthy volunteers
Trial description: GSK1018921 is a new drug under development for the treatment of schizophrenia. GSK1018921 differs from other available drugs in its mode of action and it is assumed that it may have an effect in the treatment of so-called positive symptoms such as hallucinations and negative symptoms such as lack of drive. No clinical studies have been conducted with GSK1018921 in humans until now. This is the first study where this compound is administered to humans; the study has 2 parts: Part A is a dose escalation study, Part B is a pharmacodynamic portion in a separate group of healthy smoker volunteers.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Part A:Safety pre-dose-8-15days post dose Tolerability,PK of single escalating doses. Part B: PD effects of single doses of GSK1018921 and nicotine on Quantitative Electroencephalography and MisMatch Negativity in smokers.

Timeframe: pre-dose-8-15days post dose

Secondary outcomes:

Part A:Characterise single-dose PD with Bond-Lader Visual analogue Scale,Profile of Mood State,Glycine levels.Part B:Safety pre-dose-8-15 days post dose,Tolerability,PK of single escalating doses.Amplitude and latency of P300, Effects on P50 suppression

Timeframe: pre-dose-8-15 days post dose

Interventions:
  • Drug: GSK1018921
  • Drug: Nicotine Lozenges
  • Drug: Placebo
    • Enrollment:
    27
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Daniele Ouellet, Suzanne Sutherland, Tianli Wang, Patrizia Griffini, Venkatesha Murthy. First-Time-in-Human Study with GSK1018921, a Selective GlyT1-Inhibitor: Characterization of the Exposure-Response to Dizziness, the Dose Limiting Adverse Event. [Clin Pharmacol Ther]. 2011;DOI: CLPT.2011.154:
    Medical condition
    Schizophrenia
    Product
    GSK1018921
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to July 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy volunteers as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
    • For Part B, smokers.
    • Part A: Smokers, any subject who takes any prescribed or non-prescribed medication/vitamins specified as prohibited in the protocol, substance abuse, clinically significant disease as determined by a responsible physician.
    • Part B: Non-Smokers
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Healthy volunteers as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
    • For Part B, smokers.
    Exclusion criteria:
    • Part A: Smokers, any subject who takes any prescribed or non-prescribed medication/vitamins specified as prohibited in the protocol, substance abuse, clinically significant disease as determined by a responsible physician.
    • Part B: Non-Smokers

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 14050
    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
    2008-12-07

    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 GT1109727 can be found on the GSK Clinical Study Register.
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