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

November 8, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, Sydney, New South Wales, Australia, 2031
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
  • New Zealand
      • Christchurch, New Zealand, 8011
        • GSK Investigational Site
  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • GSK Investigational Site
      • Orlando, Florida, United States, 32809
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma levels and protein binding of eltrombopag
Time Frame: Day 1 to Day 6
Day 1 to Day 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2006

Primary Completion (Actual)

March 7, 2007

Study Completion (Actual)

March 7, 2007

Study Registration Dates

First Submitted

July 28, 2006

First Submitted That Met QC Criteria

July 28, 2006

First Posted (Estimate)

August 2, 2006

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRA103452

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Purpura, Thrombocytopaenic, Idiopathic

Clinical Trials on eltrombopag

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe