Drug-drug Interaction Study of Eltrombopag and Cyclosporine in Healthy Subjects
Status:
Completed
Trial end date:
2014-12-24
Target enrollment:
Participant gender:
Summary
A drug-drug interaction study between eltrombopag and cyclosporine is being conducted to
support the use of these drugs together in subjects, such as those with severe aplastic
anemia or immune thrombocytopenia purpura. The primary objective of the study is to evaluate
the effect of cyclosporine on the pharmacokinetics of eltrombopag. This is a Phase I,
open-label, randomized, three-period cross-over study in healthy adult subjects. The study
consists of a screening visit and three treatment periods. All subjects will be randomized to
receive one of the three treatments in each treatment period separated by washout periods of
3-10 days. The total duration of a subject's participation in the study from screening to
final discharge is up to approximately 6 weeks (assuming 3 day washouts between treatment
periods). Approximately 39 healthy subjects will be enrolled with the goal of completing at
least 10 subjects per sequence (total 30).