The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Subjects will receive EDP-323 on Days 1 and 14
Subjects will receive itraconazole QD Days 5-18
Subjects will receive EDP-323 on Days 1 and 23
ICON, plc
San Antonio, Texas, United States
Cmax of EDP-323 with and without coadministration with Itraconazole
Time frame: Day 1 through Day 19
AUC of EDP-323 with and without coadministration with Itraconazole
Time frame: Day 1 through Day 19
Cmax of EDP-323 with and without coadministration with Carbamazepine
Time frame: Day 1 through Day 28
AUC of EDP-323 with and without coadministration with Carbamazepine
Time frame: Day 1 through Day 28
Cmax of EDP-323 with and without coadministration with Quinidine
Time frame: Day 1 through Day 13
AUC of EDP-323 with and without coadministration with Quinidine
Time frame: Day 1 through Day 13
Cmax of EDP-323 with and without coadministration with fluconazole
Time frame: Day 1 through Day 19
AUC of EDP-323 with and without coadministration with fluconazole
Time frame: Day 1 through Day 19
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 carbamazepine on Days 5 - 27
Subjects will receive EDP-323 on Days 1 and 8
Subjects will receive quinidine on Days 5-12
Subjects will receive EDP-323 on Days 1 and 14
Subjects will receive fluconazole on Days 5-18