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

Purpura, Thrombocytopaenic, Idiopathic Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359463
• Other study ID #: TRA103452
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2006
• Last updated: November 8, 2017
• Start date: April 18, 2006
• Est. completion date: March 7, 2007

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 7, 2007
• Est. primary completion date: March 7, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases
• Purpura
• Purpura, Thrombocytopaenic, Idiopathic
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

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

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Randwick, Sydney	New South Wales
New Zealand	GSK Investigational Site	Christchurch
United States	GSK Investigational Site	Gainesville	Florida
United States	GSK Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  New Zealand, 

References & Publications (1)

Bauman JW, Vincent CT, Peng B, Wire MB, Williams DD, Park JW. Effect of hepatic or renal impairment on eltrombopag pharmacokinetics. J Clin Pharmacol. 2011 May;51(5):739-50. doi: 10.1177/0091270010372106. Epub 2010 Jul 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels and protein binding of eltrombopag		Day 1 to Day 6
Secondary	Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams		throughout the study

External Links

•   Results for study 103452 can be found on the GSK Clinical Study Register.