Eltrombopag/Boceprevir and Eltrombopag/Telaprevir Drug-Drug Interaction Study In Healthy Adult Subjects
Status:
Completed
Trial end date:
2012-10-26
Target enrollment:
Participant gender:
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.