Actively Recruiting
A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment
Led by Edgewise Therapeutics, Inc. · Updated on 2026-03-09
32
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult, male or female, at least 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 less) for at least 3 months prior to dosing.
- Body mass index (BMI) between 18.0 and 40.0 kg/m2 at screening.
- Estimated glomerular filtration rate (eGFR) above 60 mL/min using the 2021 CKD-EPI creatinine equation.
- For mild and moderate hepatic impairment groups: generally good health except liver impairment, pulse rate between 40 and 110 bpm, QTcF interval 500 msec or less with normal or not clinically significant ECG.
- Hepatic impairment defined by Child-Pugh score: 5 to 6 for mild, 7 to 9 for moderate.
- Diagnosis of chronic (more than 6 months), stable hepatic insufficiency with no acute episodes in last 2 months.
- For normal hepatic function group: medically healthy with blood pressure between 90/40 and 150/95 mmHg, pulse rate between 40 and 100 bpm, QTcF interval 470 msec or less with normal or not clinically significant ECG.
- Liver function tests within normal limits or total bilirubin 1.5 times or less upper limit of normal.
You will not qualify if you...
- History or presence of alcohol or drug abuse within the past year prior to dosing.
- Female participants who are pregnant, breastfeeding, or have a positive pregnancy test at screening or check-in.
- Positive urine or breath alcohol test at screening or check-in.
- Unable or unwilling to refrain from drug use.
- Positive HIV test at screening.
- Blood donation or significant blood loss within 56 days prior to dosing.
- Plasma donation within 7 days prior to dosing.
- Participation in another clinical study within 30 days or 5 half-lives prior to dosing.
- For mild and moderate hepatic impairment groups: history or presence of significant medical or psychiatric conditions, severe liver disease complications within 3 months, primary biliary cholangitis or biliary obstruction, fluctuating or worsening liver function, history of liver or other solid organ transplant, frequent paracentesis over twice per month, recent portosystemic shunting procedures, recent antiviral or immune therapy for hepatitis, poorly controlled diabetes (HbA1c over 8.5%), positive hepatitis B or C viral markers with active viral load.
- For normal hepatic function group: significant medical or psychiatric illness, alcohol consumption over 14 drinks per week for males or 7 for females within 45 days, positive hepatitis B or C markers at screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The University of Miami Division of Clinical Pharmacology
Miami, Florida, United States, 33136
Actively Recruiting
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
Research Team
E
Edgewise Therapeutics, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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