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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Active Comparator | Subjects will receive a single 50 mg oral dose of eltrombopag. |
|
| Subjects with hepatic impairment | Experimental | Subjects with mild, moderate or severe hepatic impairment will receive a single 50 mg oral dose of eltrombopag. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eltrombopag | Drug | Subjects will be administered a single oral dose of 50 mg eltrombopag. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels and protein binding of eltrombopag | Day 1 to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be monitored by: - clinical lab tests - vital signs - electrocardiograms - monitoring for adverse events - physical exams - eye exams | throughout the study |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Gainesville | Florida | 32608 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20663991 | Background | 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. |
| Label | URL |
|---|---|
| Results for study 103452 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D011693 | Purpura |
| D013921 | Thrombocytopenia |
| ID | Term |
|---|---|
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| Orlando |
| Florida |
| 32809 |
| United States |
| GSK Investigational Site | Randwick, Sydney | New South Wales | 2031 | Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Christchurch | 8011 | New Zealand |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |