Clinical trial NCT00359463: Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: hepatitis C-associated thrombocytopenia
chemotherapy induced thrombocytopenia
thrombocytopenia
hepatic impairment
chronic immune thrombocytopenia purpura
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-08-02
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma levels and protein binding of eltrombopag
timeFrame: Day 1 to Day 6
Secondary outcomes:
measure: Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams
timeFrame: throughout the study
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Randwick, Sydney
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.