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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00359463 |
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.
Condition | Intervention | Phase |
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Hepatic Impairment |
Drug: eltrombopag |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
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 |
Enrollment: | 32 |
Study Start Date: | April 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
United States, Florida | |
GSK Investigational Site | |
Gainesville, Florida, United States, 32608 | |
GSK Investigational Site | |
Orlando, Florida, United States, 32809 | |
Australia, New South Wales | |
GSK Investigational Site | |
Randwick, Sydney, New South Wales, Australia, 2031 | |
Australia, South Australia | |
GSK Investigational Site | |
Adelaide, South Australia, Australia, 5000 | |
New Zealand | |
GSK Investigational Site | |
Christchurch, New Zealand, 8011 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | TRA103452 |
Study First Received: | July 28, 2006 |
Last Updated: | March 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00359463 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration |
thrombocytopenia chronic immune thrombocytopenia purpura chemotherapy induced thrombocytopenia hepatitis C-associated thrombocytopenia hepatic impairment |
Purpura Hepatitis Liver Diseases Digestive System Diseases Thrombocytopenia |
Immune Thrombocytopenia Healthy Hepatitis C Purpura, Thrombocytopenic |
Liver Diseases Digestive System Diseases |