Back to resultsStudy Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
Primary Purpose
Purpura, Thrombocytopaenic, Idiopathic
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
eltrombopag
Sponsored by
About this trial
This is an interventional treatment trial for Purpura, Thrombocytopaenic, Idiopathic focused on measuring hepatitis C-associated thrombocytopenia, chemotherapy induced thrombocytopenia, thrombocytopenia, hepatic impairment, chronic immune thrombocytopenia purpura
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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Healthy subjects
Subjects with hepatic impairment
Arm Description
Subjects will receive a single 50 mg oral dose of eltrombopag.
Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag.
Outcomes
Primary Outcome Measures
Plasma levels and protein binding of eltrombopag
Secondary Outcome Measures
Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00359463
Brief Title
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
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 18, 2006 (Actual)
Primary Completion Date
March 7, 2007 (Actual)
Study Completion Date
March 7, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Thrombocytopaenic, Idiopathic
Keywords
hepatitis C-associated thrombocytopenia, chemotherapy induced thrombocytopenia, thrombocytopenia, hepatic impairment, chronic immune thrombocytopenia purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Description
Subjects will receive a single 50 mg oral dose of eltrombopag.
Arm Title
Subjects with hepatic impairment
Arm Type
Experimental
Arm Description
Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag.
Intervention Type
Drug
Intervention Name(s)
eltrombopag
Intervention Description
Subjects will be administered a single oral dose of 50 mg eltrombopag.
Primary Outcome Measure Information:
Title
Plasma levels and protein binding of eltrombopag
Time Frame
Day 1 to Day 6
Secondary Outcome Measure Information:
Title
Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
GSK Investigational Site
City
Randwick, Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
GSK Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
20663991
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.
Results Reference
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Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
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