A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of EDG-7500 in Participants With Impaired and Normal Hepatic Function
Edgewise Therapeutics, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: All Participants * Adult, male or female, ≥ 18 years of age. * Female and male participants must follow protocol-specified contraception guidance. * Continuous non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing. * BMI ≥ 18.0 and ≤ 40.0 kg/m2 at screening. * eGFR \>60 mL/min calculated using the 2021 CKD-EPI creatinine equation. Participants with Mild and Moderate Hepatic Impairment (HI) * With the exception of HI, is in generally good health for study participation including the following: * Pulse rate is ≥ 40…
Interventions
- DrugEDG-7500
Single dose of EDG-7500
Locations (2)
- The University of Miami Division of Clinical PharmacologyMiami, Florida
- Orlando Clinical Research CenterOrlando, Florida