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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00359463

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	Drug: eltrombopag	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

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

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

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, 8001

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	TRA103452
Study First Received:	July 28, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00359463
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

thrombocytopenia
chronic immune thrombocytopenia purpura
chemotherapy induced thrombocytopenia
hepatitis C-associated thrombocytopenia
hepatic impairment

Study placed in the following topic categories:

Purpura
Hepatitis
Liver Diseases
Digestive System Diseases
Thrombocytopenia

Immune thrombocytopenia
Healthy
Hepatitis C
Purpura, Thrombocytopenic

ClinicalTrials.gov processed this record on January 16, 2009