Last updated: 11/04/2018 10:09:13

A Clinical Study to Evaluate the Pharmacokinetic Profile of SB-649868 in Elderly and Female Population

GSK study ID
OXS109143
Clinicaltrials.gov ID
NCT00534872
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A single-centre, open label, single-dose, four parallel cohorts study to investigate the pharmacokinetics, safety and tolerability of SB-649868 10mg in healthy female "non-childbearing potential", healthy male and in healthy elderly subjects
Trial description: The purpose of this study is to determine the blood levels and the tolerability of SB-649868 in Elderly and Female population
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Blood levels after a single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

Timeframe: single dose of SB-649868 after 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36 and 48 hours

Secondary outcomes:

Adverse Event, laboratory, vital signs and ECG abnormality occurred within 7-14 days from a single dose of SB-649868

Timeframe: within 7-14 days from a single dose of SB-649868

Interventions:
  • Drug: SB-649868
    • Enrollment:
    0
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Insomnia
    Product
    SB649868
    Collaborators
    Not applicable
    Study date(s)
    July 2009 to November 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • INCLUSION CRITERIA:
    • Healthy adult and elderly female and male
    Inclusion and exclusion criteria
    Inclusion criteria:
    • INCLUSION CRITERIA:
    • Healthy adult and elderly female and male
    • Female must be of non-childbearing potential
    • Body weight =50 kg EXCLUSION CRITERIA:
    • Abuse of alcohol or drugs
    • Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV
    • Use of prescription or non-prescription drugs within 7 days prior to the first dose of study medication
    • Smoking history of = 10 cigarettes a day in the last three months
    • History of cardiovascular,psychiatric,autoimmune, respiratory or relevant gastrointestinal diseases
    • Participation in clinical trial during the previous 6 months

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Other
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    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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