Drug Interaction Clinical Trial
Official title:
A Phase 1, Open-Label, 3 Period, Randomized 2-Sequence Study to Evaluate the Effect of Food and Rabeprazole, a Proton Pump Inhibitor, on the Pharmacokinetics of Fruquintinib in Healthy Subjects
The purpose of this is to evaluate the effect of food and the effect of a proton pump inhibitor (rabeprazole) on the pharmacokinetics of fruquintinib.
This study will be a single center, open label, 3-period, randomized 2-sequence study conducted with 14 healthy male or female subjects. The study will consist of a Screening Phase (Screening and Day -1), a Treatment Phase (Periods 1, 2, and 3), and an End of Study (EOS) Phase. For Periods 1 and 2, subjects will be randomized into 1 of the 2 treatment sequences, with all subjects then moving to the same treatment in Period 3. Periods 1 and 2: 14 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 possible treatment sequences: - Fed/Fasted: fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15 - Fasting/Fed: fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15 Period 3: all subjects will take rabeprazole 40 mg orally once daily in the morning from Day 23 to Day 29. On the morning of Day 29, all subjects will take rabeprazole 40 mg orally without food one hour before taking a fruquintinib 5 mg oral dose. Subjects will continue to fast until lunch. ;
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