This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin 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 itraconazole once daily from Day 5 through Day18
Subjects will receive rifampin once daily from Day 5 through Day 16
Subjects will receive EDP 305 once daily on Day 1 and Day 14
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States
Cmax of EDP-305 with and without coadministration with itraconazole
Time frame: Up to 19 days
AUC of EDP-305 with and without coadministration with itraconazole
Time frame: Up to 19 days
Cmax of EDP-305 with and without coadministration with rifampin
Time frame: Up to 17 days
AUC of EDP-305 with and without coadministration with rifampin
Time frame: Up to 17 days
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
Time frame: Up to 19 days
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