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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15. 40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29.
fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15. 40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29.
WCCT
Cypress, California, United States
AUC(0-t) of fruquintinib: area under the plasma-concentration time curve from time 0 to time of the last measurable concentration
Pharmacokinetics of fruquintinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
Time frame: Up to 36 days
AUC(0-inf) of fruquintinib
Pharmacokinetics of fruquintinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity (if data permit)
Time frame: up to 36 days
Cmax of fruquintinib
Pharmacokinetics of fruquintinib by assessment of maximum plasma fruquintinib concentration
Time frame: up to 36 days
Number of participants with treatment emergent adverse events as assessed by CTCAE v5.0
To evaluate the safety, in healthy subjects, of a single dose of 5 mg fruquintinib administered fed or fasted and with rabeprazole
Time frame: up to 36 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.