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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00359463
Recruitment Status : Completed
First Posted : August 2, 2006
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Purpura, Thrombocytopaenic, Idiopathic Drug: eltrombopag Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : April 18, 2006
Primary Completion Date : March 7, 2007
Study Completion Date : March 7, 2007


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Healthy subjects
Subjects will receive a single 50 mg oral dose of eltrombopag.
Drug: eltrombopag
Subjects will be administered a single oral dose of 50 mg eltrombopag.
Experimental: Subjects with hepatic impairment
Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag.
Drug: eltrombopag
Subjects will be administered a single oral dose of 50 mg eltrombopag.


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00359463     History of Changes
Other Study ID Numbers: TRA103452
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: November 13, 2017
Last Verified: November 2017

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

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