Hepatic Impairment (HI)Phase 1NCT07324616
A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment
A Phase 1 study testing EDG-7500 in people with Hepatic Impairment (HI), run by Edgewise Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment (HI)
- What is being tested?
- EDG-7500
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Jan 2026to 7 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: 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
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.
- Conditions
- Hepatic Impairment (HI)
- Being tested
- EDG-7500
- Keywords
- Hepatic Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDG-7500Drug
Single dose of EDG-7500
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Experimental | Not described Receives: Drug: EDG-7500 |
| Mild Hepatic Impairment | Experimental | Not described Receives: Drug: EDG-7500 |
| Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: EDG-7500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last)
Measured: Pre-dose to day 10
Area under the plasma concentration time-curve from time zero extrapolated to infinity (AUC0-inf)
Measured: Pre-dose to day 10
Maximum observed plasma concentration (Cmax)
Measured: Pre-dose to day 10
Secondary outcomes (1)
Safety: incidence of treatment-emergent adverse events
To evaluate the safety and tolerability of a single oral dose of EDG-7500 in participants with mild and moderate hepatic impairment and participants with normal hepatic function
Measured: Up to 14 days of monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start26 Jan 2026
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Impairment (HI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edgewise Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324616
- Sponsor's protocol ID
- EDG-7500-106
- Status last verified
- Jul 2026
- First submitted
- 23 Dec 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07324616
- Acronym / sponsor ID
- EDG-7500-106
- Conditions
- Hepatic Impairment (HI)
- Keywords
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Edgewise Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | Experimental | Drug: EDG-7500 |
| Mild Hepatic Impairment | Experimental | Drug: EDG-7500 |
| Moderate Hepatic Impairment | Experimental | Drug: EDG-7500 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDG-7500Single dose of EDG-7500 | Drug | Healthy Adults, Mild Hepatic Impairment, Moderate Hepatic Impairment |
Primary outcome
Area under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last)
Time frame: Pre-dose to day 10
Area under the plasma concentration time-curve from time zero extrapolated to infinity (AUC0-inf)
Time frame: Pre-dose to day 10
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose to day 10
1 secondary outcome
Safety: incidence of treatment-emergent adverse events
Time frame: Up to 14 days of monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDG-7500 in people with Hepatic Impairment (HI), run by Edgewise Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration time-curve from time zero to the last measured concentration (AUC0-last) (time frame: Pre-dose to day 10). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.