Last updated: 11/03/2018 11:06:48

Safety, tolerability and pharmacokinetics of GSK1034702 in healthy subjects

GSK study ID
110623
Clinicaltrials.gov ID
EudraCT ID
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 study to evaluate the safety, tolerability and pharmacokinetics of GSK1034702 in healthy subjects
Trial description: This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects. It will be a single-blind, randomized, placebo-controlled, single oral dose, dose-rising, cross-over study in healthy male and female (of non-child bearing potential) subjects. Subjects will be randomized into cohorts of 10 subjects and cohorts will be recruited until the pre-defined safety or PK stopping limits are reached. Each subject will receive placebo and up to 4 doses of GSK1034702 in a randomized sequence on 5 separate study occasions.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

•Safety and tolerability determined by adverse events; ECG; Holter; blood pressure, heart rate, respiration rate; clinical laboratory evaluations, pupil size & temperature.•Blood concentrations of GSK1034702.

Timeframe: 20 weeks

Secondary outcomes:

Assessment of the Bond-Lader Visual Analogue Scale.

Timeframe: 20 weeks

Assessment of exploratory PD markers: neuroendocrine markers, e.g. growth hormone.

Timeframe: 20 weeks

Relationship between GSK1034702 plasma concentrations and safety/tolerability or exploratory PD endpoints with selected pharmacodynamic and safety parameters.

Timeframe: 20 weeks

Interventions:
  • Drug: GSK1034702
  • Drug: Placebo
  • Enrollment:
    30
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cognitive Disorders
    Product
    GSK1034702
    Collaborators
    Not applicable
    Study date(s)
    May 2008 to December 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    Yes
    • Healthy as determined by a responsible physician, based on a medical evaluation including own and familial medical history, physical examination, laboratory tests and cardiac monitoring.
    • Male or female between 18 and 55 years of age.
    • A positive pre-study drug/alcohol screen.
    • A positive pre-study Hepatitis B , Hepatitis C or HIV.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, NW10 7NS
    Status
    Will Be Recruiting

    Study documents

    Scientific result summary
    Available language(s): English

    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
    2008-15-12

    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
    Results for study 110623 can be found on the GSK Clinical Study Register.
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