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.
Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.
This trial has completed. Results may be available via ClinicalTrials.gov or peer-reviewed publications.
Edgewise Therapeutics (EWTX) is the sponsoring company for this trial. BiotechSign currently grades this company D (40/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.