Last updated: 11/04/2018 05:24:25

A Study To Assess The Pharmacokinetics Of SB-742457 Formulated As A Capsule And A Tablet In Healthy Elderly Volunteers.

GSK study ID
AZ3110291
Clinicaltrials.gov ID
NCT00551772
EudraCT ID
Not applicable
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, randomised, two-part crossover study to assess the pharmacokinetics of a single dose of SB-742457 formulated as a capsule and a tablet in healthy elderly volunteers.
Trial description: SB-742457 is a 5HT6 receptor antagonist that is in development for the symptomatic treatment of mild to moderate Alzheimer’s disease . To date, all clinical trials have been conducted using a capsule formulation of SB-742457. However, it is intended to conduct all futures studies with a tablet formulation. The aim of this study is to assess the pharmacokinetic profile of SB-742457 and its major metabolites following single doses of both the capsule and tablet formulations.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

To characterise pharmacokinetics ( AUC(0-inf) and Cmax ) of SB-742457 from pre-dose to 96 hours following single doses formulated as a capsule and a tablet.

Timeframe: pre-dose to 96 hours

Secondary outcomes:

To assess safety and tolerability (adverse events, blood pressure, heart rate, 12-lead ECG, blood haematology/clinical chemistry and urinalysis) of SB-742457 following single doses formulated as a capsule and a tablet over the 6 week study period.

Timeframe: 6 week study period

Interventions:
  • Drug: SB-742457
    • Enrollment:
    12
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Alzheimer's Disease
    Product
    SB742457
    Collaborators
    Not applicable
    Study date(s)
    August 2007 to September 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    60 - 85 Years
    Accepts healthy volunteers
    yes
    • Inclusion criteria:
    • Men or surgically sterile or post-menopausal women
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Men or surgically sterile or post-menopausal women
    • Healthy as judged by a responsible physician. No clinically significant abnormality identified on the medical or lab evaluation.
    • BMI between 18.5 and 32.0 kg/m2 Exclusion criteria:
    • A positive pre-study urine screen for drugs of abuse
    • Abuse of alcohol
    • Subjects who smoke more than 10 cigarettes or equivalent a day.
    • Use of prescription drugs as well as herbal and dietary supplements within 7 days prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
    • Where participation in the study would result in donation of blood in excess of 500ml within a 56 day period.
    • Has a history or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
    • The subject has received an investigational drug or participated in another research trial within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
    • Known or suspected history of seizures, including febrile seizures, unexplained recent loss of consciousness or history of significant head trauma with loss of consciousness.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-21-09

    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

    Additional information
    Not applicable
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