A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment

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

NCT07324616•Edgewise Therapeutics, Inc.

View on ClinicalTrials.gov

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

18 - No limit 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 bpm and ≤ 110 bpm at screening.
•* QTcF interval is ≤ 500 msec and has ECG findings considered normal or not clinically significant.
+10 more criteria

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.
+14 more criteria

Locations (2)

The University of Miami Division of Clinical Pharmacology

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Key Dates

Start Date

January 26, 2026

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

Hepatic Impairment (HI)

Interventions

EDG-7500

DRUG

Contacts

Edgewise Therapeutics, Inc.

CONTACT

720-262-7002 cardiacstudies@edgewisetx.com

A Varegacestat Hepatic Impairment Study

NCT06841315

Healthy VolunteerHepatic Impairment (HI)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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