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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00359463
First received: July 28, 2006
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hepatic Impairment
Purpura, Thrombocytopenic, Idiopathic
Drug: eltrombopag
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Plasma levels and protein binding of eltrombopag [ Time Frame: Day 1 to Day 6 ]

Secondary Outcome Measures:
  • Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams [ Time Frame: throughout the study ]

Enrollment: 32
Study Start Date: April 2006
Intervention Details:
    Drug: eltrombopag
    Other Name: eltrombopag
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359463

Locations
United States, Florida
GSK Investigational Site
Gainesville, Florida, United States, 32608
GSK Investigational Site
Orlando, Florida, United States, 32809
Australia, New South Wales
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8011
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00359463     History of Changes
Other Study ID Numbers: TRA103452
Study First Received: July 28, 2006
Last Updated: October 25, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
hepatitis C-associated thrombocytopenia
chemotherapy induced thrombocytopenia
thrombocytopenia
hepatic impairment
chronic immune thrombocytopenia purpura

Additional relevant MeSH terms:
Liver Diseases
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Digestive System Diseases
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on November 23, 2014