A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
72
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States
Cmax of EDP-938 with and without coadministration with itraconazole
Time frame: Up to 19 days
AUC of EDP-938 with and without coadministration with itraconazole
Time frame: Up to 19 days
Cmax of EDP-938 with and without coadministration with rifampin
Time frame: Up to 17 days
AUC of EDP-938 with and without coadministration with rifampin
Time frame: Up to 17 days
Cmax of EDP-938 with and without coadministration with quinidine
Time frame: Up to 13 days
AUC of EDP-938 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 itraconazole once daily from Day 5 to Day 18
Subjects will receive rifampin once daily from Day 5 to Day 16
Subjects will receive quinidine once daily from Day 5 to Day 12