A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
48
Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)
Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)
Subjects will receive one dose of cyclosporine on Day 5
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States
Cmax of EDP-938 with and without coadministration with cyclosporine
Time frame: Up to 12 days
AUC of EDP-938 with and without coadministration with cyclosporine
Time frame: Up to 12 days
Cmax of EDP-938 with and without coadministration with prednisone
Time frame: Up to 21 days
AUC of EDP-938 with and without coadministration with prednisone
Time frame: Up to 21 days
Safety measured by adverse events
Time frame: Up to 21 days
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Subjects will receive prednisone once daily from Day 5 to Day 14