A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
ICON, plc.
Lenexa, Kansas, United States
Cmax of EDP-235 with and without coadministration with Itraconazole
Time frame: Day 1 through Day 19
AUC of EDP-235 with and without coadministration with Itraconazole
Time frame: Day 1 through Day 19
Cmax of EDP-235 with and without coadministration with Carbamazepine
Time frame: Day 1 through Day 26
AUC of EDP-235 with and without coadministration with Carbamazepine
Time frame: Day 1 through Day 26
Cmax of EDP-235 with and without coadministration with Quinidine
Time frame: Day 1 through Day 13
AUC of EDP-235 with and without coadministration with Quinidine
Time frame: Day 1 through Day 13
Safety measured by adverse events
Time frame: Up to 34 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subjects will receive itraconazole QD Days 5-18
Subjects will receive carbamazepine BID Days 5-23 and Days 24-27
Subjects will receive quinidine BID Days 5-12