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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Purpura, Thrombocytopaenic, Idiopathic

Intervention / Treatment
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* Drug: eltrombopag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Healthy subjects<br>Subjects will receive a single 50 mg oral dose of eltrombopag. | Drug: eltrombopag<br>* Subjects will be administered a single oral dose of 50 mg eltrombopag.<br>|
| Experimental: Subjects with hepatic impairment<br>Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag. | Drug: eltrombopag<br>* Subjects will be administered a single oral dose of 50 mg eltrombopag.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels and protein binding of eltrombopag |  | Day 1 to Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams |  | throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis C-associated thrombocytopenia, chemotherapy induced thrombocytopenia, thrombocytopenia, hepatic impairment, chronic immune thrombocytopenia purpura