This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Subjects will receive fluconazole once daily from Day 5 to Day 18
Subjects will receive quinidine twice daily from Day 5 to Day 12
Subjects will receive a single dose of EDP-305 on Day 1 and Day 14
Pharmaceutical Research Associates, Inc.,
Salt Lake City, Utah, United States
Cmax of EDP-305 with and without coadministration with fluconazole
Time frame: Up to 19 days
AUC of EDP-305 with and without coadministration with fluconazole
Time frame: Up to 19 days
Cmax of EDP-305 with and without coadministration with quinidine
Time frame: Up to 13 days
AUC of EDP-305 with and without coadministration with quinidine
Time frame: Up to 13 days
Safety measured by adverse events
Time frame: Up to 25 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Subjects will receive a single dose of EDP-305 on Day 1 and Day 8