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

Phase 1

Completed

• Conditions: Purpura, Thrombocytopaenic, Idiopathic
• Interventions: Drug: eltrombopag

• Registration Number: NCT00359463
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-18
• Study First Submitted: 2006-07-28
• Study First Submitted QC: 2006-07-28
• Study First Posted: 2006-08-02
• Primary Completion: 2007-03-07
• Study Completion: 2007-03-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-08
• Last Update Posted: 2017-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy subjects	eltrombopag	Subjects will receive a single 50 mg oral dose of eltrombopag.
Subjects with hepatic impairment	eltrombopag	Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag.

Primary Outcome Measures

Name	Time	Method
Plasma levels and protein binding of eltrombopag	Day 1 to Day 6

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇿 Christchurch, New Zealand