Last updated: 11/04/2018 06:09:08

A healthy volunteer study to investigate the relative bioavailability of two forms of GSK598809 capsules.

GSK study ID
DAN111283
See study documents
Clinicaltrials.gov ID
NCT00728897
EudraCT ID
2008-001967-12
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, single dose, three-way crossover study to investigate the relative bioavailability of a 100mg capsule compared to four 25mg GSK598809 capsules and the effect of food on the pharmacokinetics of the 100mg capsule in healthy male and female volunteers.
Trial description: Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because we plan to have only single capsules administered in the later phase clinical trials but we have not had a 100mg strength before. As this is a new previously untested strength we need to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess the effect of high fat food on the PK of the 100mg capsule. The study is planned to consist of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There will be a week wash out between each dose. In the three dosing periods subjects will either received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or 100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14 days after the final dose. It is expected that the total duration of the study should be approximately eight weeks.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.

Timeframe: Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours

Secondary outcomes:

Safety and Tolerability: cardiovascular variables, vital signs, clinical labs, movement scales, prolactin, GH and TSH levels over 96 hours post dosing. Continuous adverse event monitoring from dosing until study conclusions.

Timeframe: Up to 96 hours

Interventions:
  • Drug: GSK598809 new formulation
  • Drug: GSK598809 old formulation
    • Enrollment:
    16
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Substance Dependence
    Product
    GSK598809
    Collaborators
    Not applicable
    Study date(s)
    July 2008 to July 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion:
    • Healthy as determined by responsible physician.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion:

      • Healthy as determined by responsible physician.
      • Male or female between 18 to 65 years old.
      • Females of non-child bearing potential and females of child-bearing potential that agree to use appropriate method of contraception for appropriate amount of time.
      • Males that agree to use appropriate method of contraception for appropriate amount of time.
      • Neither too fat nor too thin.
      • Capable of giving written informed consent and being compliant with requirements within the informed consent. Exclusion:
      • Any current medical or psychiatric illness.
      • Any history of chronic medical or psychiatric illnesses.
      • Previous or current alcohol or drug abuse/dependence including nicotine.
      • Female subjects must not be breastfeeding or been breastfeeding for a month.
      • Serum prolactin exceeding normal range.
      • Personal or family history of prolonged QTc syndrome.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SE1 1YR
    Status
    Study Complete
    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
    2008-29-07

    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 DAN111283 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
    Visit website