Last updated: 06/12/2020 07:55:52

Radiolabel Study In Healthy Volunteers For Insomnia-Targeting Drug

GSK study ID
OXS109139
See study documents
Clinicaltrials.gov ID
NCT00520663
EudraCT ID
2007-000761-38
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 study to determine the excretion, balance and pharmacokinetics of SB649868 after a single oral administration of 14C-SB649868 in healthy volunteers
Trial description: The purpose of this study is to define the absorption, breakdown and excretion of a single dose of radiolabelled SB-649868 and its breakdown products by measuring their concentration in blood, urine and faeces over a 7-10 day period. “Radiolabelled” means that the test drug has a radioactive component to help us track the drug. The safety and tolerability of the test drug will also be assessed.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Excretion of SB649868 by measuring radioactivity in urine and faeces

Timeframe: over 7-10 days.

Plasma levels of SB-649868 by measuring drug levels and radioactivity in plasma. Plasma, urine,faeces samples to study the metabolites of SB649868.

Timeframe: over 4 days

Secondary outcomes:

Safety and tolerability of 14C-SB649868 by adverse event monitoring, lab samples and cardiovascular monitoring.

Timeframe: over the course of the study

Interventions:
  • Drug: 14C-SB649868
    • Enrollment:
    8
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Sleep Initiation and Maintenance Disorders
    Product
    SB649868
    Collaborators
    Not applicable
    Study date(s)
    June 2007 to August 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Male
    Age
    30 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy males, aged 30-55 years inclusive.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy males, aged 30-55 years inclusive.
    • Body weight more or equal to 50kg with a BMI (body mass index) between 18.5-29.9kg/m2 inclusive.
    • Healthy as based on a medical evaluation consisting of medical history, physical examination, lab tests on blood and urine and cardiovascular monitoring. LH, FSH and testosterone hormones must be within normal reference range. Exclusion criteria:
    • Positive urine drug screen or alcohol breath test at screening visit.
    • Average weekly alcohol intake of more than 21 units or average daily intake of more than 3 units.
    • Grapefruit or grapefruit juice intake 7 days before dosing and until the last blood sample is taken.
    • Any subject who is not prepared to eat standard meals in the clinic or is a vegetarian.
    • Participated in a clinical trial for a new drug within 30 days or 5 half-lives or twice the duration of that drugs effect before the dosing day for this study.
    • Exposure to 4 new drugs in clinical trials within the last 12 months before dosing in this study.
    • Use of any medications (prescribed or non-prescribed including vitamins and herbal supplements) within 7 days before dosing in this study.
    • Participation in this study would result in the subject donating more than 500ml in a 56 day period.
    • Regular use of tobacco or nicotine-containing products within 6 months of screening.
    • Unwillingness to abstain from sexual intercourse with pregnant or lactating women from dosing until 84 days after.
    • Unwillingness to use contraception and have female partner use contraception if she could become pregnant for 84 days after dosing.
    • Unwillingness to abstain from strenuous physical activity for 48 hours before screening and in the 72 hours before and 48 hours after the treatment period.
    • Administration of radiolabelled substances or exposure to significant radiation (eg serial X-rays or CT scans, barium meal etc)within the past 12 months from screening.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Tranent, West Lothian, United Kingdom, EH33 2NE
    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
    2007-10-08

    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 109139 can be found on the GSK Clinical Study Register.
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