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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00359463

Enrollment

Registered

2006-08-02

Start date

2006-04-18

Completion date

2007-03-07

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Keywords

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

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.

Interventions

DRUGeltrombopag

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Plasma levels and protein binding of eltrombopag	Day 1 to Day 6

Secondary

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

Countries

Australia, New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026