EDG-7500 for adults with reduced liver function

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

This test will see how a single dose of EDG-7500 is processed in the blood of adults with mild or moderate liver impairment compared with people who have normal liver function.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Edgewise Therapeutics, Inc. (industry)
• Locations: 2 sites (Miami, Florida and 1 other locations)
• Trial ID: NCT07324616 on ClinicalTrials.gov

What this trial studies

This Phase 1, single-dose study compares the pharmacokinetics of EDG-7500 in adults with mild or moderate hepatic impairment versus adults with normal liver function. Participants are grouped by Child-Pugh classification (mild = Class A, moderate = Class B) and must meet general health, BMI, smoking, and kidney function criteria. Blood samples will be taken over a defined period after dosing to measure drug levels, and safety monitoring (including ECGs and vital signs) will be performed. The study is sponsored by Edgewise Therapeutics and conducted at investigational sites in Florida.

Who should consider this trial

Good fit: Adults aged 18 or older with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment who meet screening health criteria (BMI 18–40, eGFR >60 mL/min, limited smoking, contraceptive requirements) are the intended participants.

Not a fit: People with severe liver impairment (Child-Pugh C), significant uncontrolled medical conditions, eGFR ≤60 mL/min, heavy smoking, or other disqualifying health issues are unlikely to benefit or be eligible for this study.

Why it matters

Potential benefit: If successful, the results could guide safe dosing recommendations for people with liver impairment and support further development of EDG-7500 for that population.

How similar studies have performed: Pharmacokinetic studies in hepatic impairment are commonly used and often successfully inform dosing adjustments, but EDG-7500’s behavior in this setting has not been previously reported.

Eligibility criteria

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 bpm and ≤ 110 bpm at screening.
  * QTcF interval is ≤ 500 msec and has ECG findings considered normal or not clinically significant.
* Has impaired hepatic function as defined by the Child-Pugh classification for severity of liver disease and has a Child-Pugh score in line with one of the following HI cohorts at screening:

  * Mild HI (Class A): Child-Pugh score of 5 to 6, inclusive.
  * Moderate HI (Class B): Child-Pugh score of 7 to 9, inclusive.
* Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency.

Participants with Normal Hepatic Function:

-Medically healthy, including the following:

* Blood pressure is ≥ 90/40 mmHg and ≤ 150/95 mmHg.
* Pulse rate is ≥ 40 bpm and ≤ 100 bpm.
* QTcF interval is ≤ 470 msec and has ECG findings considered normal or not clinically significant.
* Liver function test including ALT ≤ ULN, AST ≤ ULN, and total bilirubin ≤1.5x ULN.

Exclusion Criteria:

All Participants

* History or presence of alcohol or drug abuse within the past 1 year prior to dosing.
* Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating or breastfeeding.
* Positive urine or breath alcohol results at screening or check-in. Unable to refrain from or anticipates the use of any drugs.
* Positive results for HIV at screening.
* Donation of blood 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 within 5 half-lives (if known), prior to dosing.

Participants with Mild and Moderate HI

* With the exception of HI, history or presence of clinically significant medical or psychiatric condition or disease, or any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study.
* History of severe complications of liver disease within the preceding 3 months of screening.
* Primary biliary cholangitis or biliary obstruction at screening.
* Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing.
* History of liver or other solid organ transplantation.
* Requires paracentesis more often than 2 times per month.
* Transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting within 90 days prior to screening.
* Received antiviral and/or immune modulating therapy for active hepatitis infection within 90 days prior to dosing.
* Diabetic participants with HbA1c \> 8.5% at screening.
* Positive for HBsAg or HBcAb and has positive hepatitis B virus DNA at screening.
* Positive for HCV and has a detectable HCV viral load at screening.

Participants with Normal Hepatic Function

* History or presence of clinically significant medical or psychiatric condition or disease, or any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study.
* Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening.
* Positive result for HBsAg or HCV at screening.

Where this trial is running

Miami, Florida and 1 other locations

• The University of Miami Division of Clinical Pharmacology — Miami, Florida, United States (RECRUITING)
• Orlando Clinical Research Center — Orlando, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Edgewise Therapeutics, Inc.

Conditions: Hepatic Impairment