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

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.

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Key information

Conditions

Purpura, Thrombocytopaenic, Idiopathic Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Signs and Symptoms Skin Manifestations Thrombocytopenia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Randwick, Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eltrombopag

Drug

Subjects will be administered a single oral dose of 50 mg eltrombopag.

Primary outcomes

Plasma levels and protein binding of eltrombopag

Time frame: 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

Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Aug 2, 2006
Registry last updated: Nov 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed