Actively Recruiting
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
Led by Edgewise Therapeutics, Inc. · Updated on 2026-03-09
32
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying EDG-7500 to understand how it behaves in the blood after a single dose in adults with different levels of liver function, including those with normal liver function and those with mild or moderate hepatic impairment. This Phase 1 trial also evaluates the safety of EDG-7500 in these groups to see how liver impairment affects the drug's presence and tolerability. Participants receive one oral dose of EDG-7500. The study includes three groups: healthy adults with normal liver function, adults with mild hepatic impairment, and adults with moderate hepatic impairment. The trial is open-label, meaning all participants know they are receiving EDG-7500. There are no placebo groups or blinding methods used. During the study, researchers monitor the amount of EDG-7500 in the blood over time, up to 10 days after dosing, measuring key levels such as maximum concentration and overall exposure. Safety is also tracked by observing any treatment-related side effects for up to 14 days. Participants undergo health assessments including blood tests, vital signs, and heart monitoring to ensure safety throughout the study timeline, which starts with screening and continues through follow-up.
CONDITIONS
Brief 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, 18 years of age or older
- Follow protocol contraception guidance (for females and males)
- Continuous non-smoker or moderate smoker (10 or fewer cigarettes per day) for at least 3 months before dosing
- Body mass index between 18.0 and 40.0 kg/m2 at screening
- Estimated glomerular filtration rate (eGFR) greater than 60 mL/min at screening
- For mild and moderate hepatic impairment groups: generally healthy except for liver impairment
- Pulse rate between 40 and 110 bpm at screening
- QTcF interval 500 msec or less with normal or not clinically significant ECG findings
- Child-Pugh score 5 to 6 for mild hepatic impairment or 7 to 9 for moderate hepatic impairment
- Diagnosis of chronic, stable hepatic insufficiency for more than 6 months
- For normal hepatic function group: medically healthy with blood pressure 90/40 to 150/95 mmHg
- Pulse rate 40 to 100 bpm
- QTcF interval 470 msec or less with normal or not clinically significant ECG findings
- Liver function tests within normal limits or total bilirubin less than or equal to 1.5 times the upper limit of normal
You will not qualify if you...
- History or presence of alcohol or drug abuse within 1 year before dosing
- Positive pregnancy test, lactating, or breastfeeding female
- Positive urine or breath alcohol test at screening or check-in
- Unable or anticipates inability to refrain from drug use
- Positive HIV test at screening
- Blood donation or significant blood loss within 56 days before dosing
- Plasma donation within 7 days before dosing
- Participation in another clinical study within 30 days or 5 half-lives before dosing
- For mild and moderate hepatic impairment groups: clinically significant medical or psychiatric conditions, severe liver complications within 3 months before screening, primary biliary cholangitis or biliary obstruction, fluctuating or rapidly worsening liver function, history of liver or other organ transplant, frequent paracentesis (more than twice monthly), recent portosystemic shunt procedures, recent antiviral or immune therapy for hepatitis, diabetes with HbA1c over 8.5%, positive hepatitis B or C viral tests with active infection
- For normal hepatic function group: clinically significant medical or psychiatric conditions, alcohol consumption exceeding 14 drinks per week for males or 7 for females within 45 days before screening, positive hepatitis B or C test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single oral dose of EDG-7500 to evaluate its pharmacokinetics.
1 dosing visit (in-person) with follow-up assessments
Duration - Up to 14 days
Participants are monitored for safety and treatment-emergent adverse events after dosing.
Multiple follow-up visits over 14 days
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.
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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