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Clinical Trial Summary

The purpose of the current Phase I, open-label, three-period, single sequence, crossover study, TPL116010, is to evaluate the potential drug-drug interaction between eltrombopag (ELT) and bocrprevir (BCP) and between ELT and telaprevir (TLP) in healthy subjects. In this study there will be a screening visit, three treatment periods, and a follow-up visit. In Period 1, subjects will receive a single dose of ELT on Day 1, and pharmacokinetic (PK) sampling will occur for 72 hours. In Period 2, subjects will receive BCP/TLP for 10 days with PK sampling for 8 hours. In Period 3, subjects will receive a single dose of ELT with BCP/TLP on Day 1 only with PK sampling for 72 hours. Subjects will return for a follow-up visit within 10 to 14 days of the last dose of study drugs. The total duration of the study from Screening to Follow-up will be approximately 9 weeks.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01657552
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date August 1, 2012
Completion date October 26, 2012

See also
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Withdrawn NCT01055600 - Milk-only Lactation Study for Patients on Eltrombopag Phase 4
Completed NCT01147809 - Safety and Efficacy Study for Solid Tumor Patients Treated With Eltrombopag Phase 2
Terminated NCT02158936 - A Study of Eltrombopag or Placebo in Combination With Azacitidine in Subjects With International Prognostic Scoring System (IPSS) Intermediate-1, Intermediate-2 or High-risk Myelodysplastic Syndromes (MDS) Phase 3
Completed NCT00358540 - Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide Phase 1
Completed NCT00102726 - SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adult Cancer Patients Receiving Chemotherapy Phase 2
Completed NCT01235988 - Meta-analysis - Eltrombopag N/A
Completed NCT01236014 - Indirect Comparison Between Eltrombopag & Romiplostim N/A