This study will be a 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in Period 2.
This study will be a single center, open label, fixed-sequence crossover, 2-period study conducted with 14 healthy male or female subjects. Subjects will be administered surufatinib alone in Period 1 and in combination with itraconazole in Period 2. PK samples will be collected through out both study periods.Subjects will be confined in the clinic from check-in on Day -1 through the end-of study visit on Day 15.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
Surufatinib: 200 mg as single dose on Days 1 and 9
Itraconazole: 200 mg BID on Day 5, then 200 mg QD on Days 6 to 14
Covance Clinical Research Unit
Dallas, Texas, United States
AUC (0-t) of Surufatinib
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration time curve from zero to the last measurable concentration
Time frame: Up to Day 15
AUC of Surufatinib
Pharmacokinetics of surufatinib by assessment of area under the plasma concentration curve from zero extrapolated to infinity
Time frame: Up to Day 15
Cmax of Surufatinib
Pharmacokinetics of Surufatinib by assessment of maximum plasma Surufatinib concentration
Time frame: Up to Day 15
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 surufatinib administered with and without food
Time frame: Up to Day 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.