A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
89
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States
Cmax of tacrolimus with and without coadministration with EDP-938
Time frame: up to 29 days
AUC of tacrolimus with and without coadministration with EDP-938
Time frame: up to 29 days
Cmax of dabigatran with and without coadministration with EDP-938
Time frame: up to 17 days
AUC of dabigatran with and without coadministration with EDP-938
Time frame: up to 17 days
Cmax of rosuvastatin with and without coadministration with EDP-938
Time frame: up to 17 days
AUC of rosuvastatin with and without coadministration with EDP-938
Time frame: up to 17 days
Cmax of midazolam with and without coadministration with EDP-938
Time frame: up to 17 days
AUC of midazolam with and without coadministration with EDP-938
Time frame: up to 17 days
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 tacrolimus once daily on Day 1 and Day 24
Subjects will receive dabigatran once daily on Day 1 and Day 13
Subjects will receive rosuvastatin once daily on Day 1 and Day 13
Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)
Subjects will receive midazolam once daily on Day 1 and Day 16