Miami, FLNCT07324616Now EnrollingIRB Ready

Hepatic Impairment (HI) Clinical Trial in Miami, FL

Access cutting-edge hepatic impairment (hi) treatment through this clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by Edgewise Therapeutics, Inc.

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Expert Care in Miami

Access hepatic impairment (hi) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hepatic impairment (hi) treatment provided free

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Check if you qualify for this hepatic impairment (hi) clinical trial in Miami, FL

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Hepatic Impairment (HI) Study in Miami

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.

Sponsor: Edgewise Therapeutics, Inc.

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT07324616) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hepatic Impairment (HI) Treatment Options in Miami, FL

If you're searching for hepatic impairment (hi) treatment options in Miami, FL, this clinical trial (NCT07324616) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hepatic impairment (hi) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hepatic impairment (hi) clinical trials near you to find additional studies recruiting in your area.

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