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New treatment option for Hepatic Impairment (HI)
Official title A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment
ClinicalTrials.gov ID: NCT07324616
What this study is testing
What is EDG-7500?
EDG-7500 is an investigational medicine, being studied as a potential treatment for hepatic impairment (hi).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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...
- Alcohol consumption \> 14 drinks per week for males (7 for females) within 45 days of screening.
- Positive result for HBsAg or HCV at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Orlando, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Orlando, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.