The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of liver function impairment versus participants with normal liver function. The safety of EDG-7500 in adult participants with different levels of liver function impairment will also be evaluated in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Single dose of EDG-7500
The University of Miami Division of Clinical Pharmacology
Miami, Florida, United States
RECRUITINGOrlando Clinical Research Center
Orlando, Florida, United States
RECRUITINGArea under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last)
Time frame: Pre-dose to day 10
Area under the plasma concentration time-curve from time zero extrapolated to infinity (AUC0-inf)
Time frame: Pre-dose to day 10
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose to day 10
Safety: incidence of treatment-emergent adverse events
To evaluate the safety and tolerability of a single oral dose of EDG-7500 in participants with mild and moderate hepatic impairment and participants with normal hepatic function
Time frame: Up to 14 days of monitoring
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