Relative Bioavailibilty for Pediatric Powder for Suspension (PfOS) Formulation and Food Effect
Status:
Completed
Trial end date:
2010-04-07
Target enrollment:
Participant gender:
Summary
This is a randomized, open-label, five-period, balanced crossover study conducted in
approximately 40 healthy adult subjects enrolled at one study center in the USA. Subjects
receive five eltrombopag treatments: tablet fasted, Powder for Oral Suspension (PfOS) fasted,
PfOS with a high calcium meal, PfOS 2 hours prior to a high calcium meal, and PfOS 2 hours
after a high calcium meal, and each treatment is a single 25 mg dose. There is a 10 to 14 day
washout between periods, and between the last dose of study drug and the follow-up visit.
During each treatment period, subjects undergo serial PK sampling over 72 hours for
measurement of plasma eltrombopag concentrations. Safety is assessed by vital signs, clinical
safety laboratory assessments, and adverse events reporting.