Last updated: 11/04/2018 10:07:21

Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

GSK study ID
OTA105101
See study documents
Clinicaltrials.gov ID
NCT00457925
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, two period study to determine the excretion balance and pharmacokinetics of [14C]-GSK221149A, administered as single doses of an oral solution and an intravenous infusion to healthy female volunteers
Trial description: This is a phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GSK221149A
    • Enrollment:
    6
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Obstetric Labour, Premature
    Product
    retosiban
    Collaborators
    Not applicable
    Study date(s)
    October 2006 to December 2006
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female
    Age
    30 - 55 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy adult, non-smoking females
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy adult, non-smoking females
    • Aged between 30
    • 55 years old, and BMI of between 19 and 32
    • Not of child-bearing potential Exclusion criteria:
    • No clinically significant findings on clinical examination, medical examination and blood tests.
    • Radiation exposure over previous 3 years is greater than 10mSv
    • History of bleeding or gastric problems

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    MADISON, Wisconsin, United States, 53704
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    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
    2006-29-12

    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

    Additional information
    Not applicable
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    Access to clinical trial data by researchers
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