EDG-7500 for Liver Disease

Not yet recruiting at 1 trial location
ET
Overseen ByEdgewise Therapeutics, Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Edgewise Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Adults over 18 with varying levels of liver function, including those with mild to moderate hepatic impairment, can join this trial. Participants must be non-smokers or moderate smokers, have a BMI between 18 and 40 kg/m2, and normal kidney function. They should also agree to follow contraception guidelines.

Inclusion Criteria

My heart rate is between 40 and 110 beats per minute.
My liver function is slightly impaired (Child-Pugh A).
I will follow the study's rules for birth control.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of EDG-7500

Single dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EDG-7500

Trial Overview

The study is testing EDG-7500 in adults to see how different levels of liver health affect the drug's presence in the blood after one dose. It will compare results from those with normal liver function to those with impaired liver function.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Group II: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Group III: Healthy AdultsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Edgewise Therapeutics, Inc.

Lead Sponsor

Trials
13
Recruited
1,000+