This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
29
Each subject will receive a single dose of EDP 305 on Day 1.
American Research Corporation at The Texas Liver Institute
San Antonio, Texas, United States
Pharmaceuticals Research Associates
Prague, Czechia
Summit SRO
Bratislava, Slovakia
Cmax of EDP 305
Time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
AUCinf of EDP 305
Time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
t1/2 of EDP 305
Time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
CL/F of EDP 305
Time frame: From pre-dose on Day 1 until 216 hour post-dose (Day 10)
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
Time frame: From Screening up to Day 14
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.