Last updated: 11/04/2018 12:55:56

Study Of Eltrombopag in Healthy Subjects and Volunteers with Mild, Moderate or Severe Hepatic Impairment

GSK study ID
TRA103452
See study documents
Clinicaltrials.gov ID
NCT00359463
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, Non-Randomized Pharmacokinetic and Safety Study of a Single Oral dose of 50mg Eltrombopag in Healthy Subjects and in Volunteers with Mild, Moderate or Severe Hepatic Impairment
Trial description: The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems. The study is also being done to 1) check on how well the study drug is tolerated by healthy subjects versus those with liver problems and 2) to check if liver impairment affects how the study drug binds to protein in the blood.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Plasma levels and protein binding of eltrombopag

Timeframe: Day 1 to Day 6

Secondary outcomes:

Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams

Timeframe: throughout the study

Interventions:
  • Drug: eltrombopag
    • Enrollment:
    33
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Bauman J, Peng B, Williams D, Wook Park J. Effect of Hepatic or Renal Impairment on Eltrombopag Pharmacokinetics. [J Clin Pharmacol]. 2010; 0: 0091270010372106v1 .
    Bauman JW, Vincent CT, Peng B, Williams DD, Wook Park J.Effect of Hepatic or Renal Impairment on Eltrombopag Pharmacokinetics.J Clin Pharmacol.2011;51(5):739-750
    Medical condition
    Purpura, Thrombocytopaenic, Idiopathic
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    April 2006 to March 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion criteria:
    • Healthy or have liver impairment
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Healthy or have liver impairment
    • Females(the following requirement applies only if able to have children): agree to doctor approved birth control methods, or partner has had a vasectomy.
    • Body mass index (BMI-within acceptable range)
    • Negative drug, alcohol, and HIV tests Exclusion criteria:
    • Taking a medication or therapy not approved by the study doctor
    • Rapidly changing liver function
    • Kidneys not working well
    • Drug or alcohol abuse within past 6 months
    • Used an investigational drug in the past 30 days
    • Females that are pregnant or nursing
    • Have active hepatitis B or C
    • History of blood disorders
    • History of various heart conditions (as noted by study doctor)
    • Blood clotting problems or blood abnormalities

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Randwick, Sydney, New South Wales, Australia, 2031
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Gainesville, Florida, United States, 32608
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Christchurch, New Zealand, 8011
    Status
    Will Be Recruiting
    Contact us
    Location
    GSK Investigational Site
    Adelaide, South Australia, Australia, 5000
    Status
    Recruiting
    Contact us
    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32809
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2007-07-03

    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 103452 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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