Renal ImpairmentsPhase 1NCT07034768
A Study to Evaluate EDG-7500 in People With Renal Impairment
A Phase 1 study testing EDG-7500 in people with Renal Impairments, 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 kidney function impairment versus participants with normal kidney function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairments
- What is being tested?
- EDG-7500
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jul 2025to 26 Dec 2025
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants
- Adult, male or female, 18-75 years of age, inclusive
- Female and male participants must follow protocol-specified contraception guidance
- Continuous non-smoker or light smoker (≤ 5 cigarettes per day or equivalent) for at least 3 months prior to dosing
- BMI ≥ 18.0 and ≤ 40.0 kg/m2 at the screening visit.
- Participants with Severe, Moderate and Mild Renal Impairment (RI)
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- With the exception of RI and other stable diseases, participant is sufficiently healthy for study participation including the following:
- Heart rate ≥ 40 bpm and ≤ 110 bpm.
- QTcF interval ≤ 500 msec and has ECG findings considered normal or not clinically significant.
- Liver function test including ALT ≤ ULN, AST ≤ ULN, and total bilirubin ≤ 1.5 ULN
- Has impaired renal function as determined by eGFR:
- eGFR <30 mL/min, not requiring hemodialysis, for participants with severe RI.
- eGFR ≥30 but <60 mL/min for participants with moderate RI.
- eGFR ≥60 but <90 mL/min for participants with mild RI.
- Has stable renal function with no clinically significant change in renal status at least 28 days prior to dosing and is not currently or has not been previously on dialysis for at least 1 year.
- Participants with Normal Renal Function
- Medically healthy, including the following:
- Blood pressure ≥ 90/40 mmHg and ≤ 150/95 mmHg
- Heart rate ≥ 40 bpm and ≤ 100 bpm
- QTcF interval ≤ 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
- Normal renal function with eGFR ≥ 90 mL/min
Who cannot join
- All Participants
- History or presence of alcohol or drug abuse within the past 2 years prior to dosing.
- Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating.
- Positive urine or breath alcohol results. Unable to refrain from or anticipates the use of any drugs.
- Positive results for HIV, HBsAg, or HCV.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
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- Plasma donation within 7 days prior to the first dosing.
- Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to dosing.
- Participants with Severe, Moderate, and Mild RI (Cohorts 1, 2, and 4)
- History or presence of renal artery stenosis.
- Renal transplant or nephrectomy in ≤ 5 years.
- Diabetes confirmed with HbA1c > 8.5%.
- Participants with Normal Renal Function (Cohort 3)
- -History of any illness that might confound the results of the study or poses an additional risk to the participant by their participation in the study.
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, 2-Part, Open-Label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of EDG-7500 in Participants With Impaired and Normal Renal 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 kidney function impairment versus participants with normal kidney function. The safety of EDG-7500 in participants with different levels of kidney function impairment will also be evaluated in this study.
- Conditions
- Renal Impairments
- Being tested
- EDG-7500
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 Volunteers | Experimental | Not described Receives: Drug: EDG-7500 |
| Severe Renal Impairment | Experimental | Not described Receives: Drug: EDG-7500 |
| Moderate Renal Impairment | Experimental | Not described Receives: Drug: EDG-7500 |
| Mild Renal Impairment | Experimental | This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment Receives: Drug: EDG-7500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time zero to last quantifiable concentration (AUC0-last)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-last)
Measured: Pre-dose to day 11
Area under the curve from time zero to extrapolated infinite time (AUC0-inf)
Area under the plasma concentration time-curve from zero to extrapolated infinite time (AUC0-inf)
Measured: Pre-dose to day 11
Maximum observed plasma concentration (Cmax)
Measured: Pre-dose to day 11
Observed plasma concentration at the end of the dosing interval (C24)
Measured: Pre-dose to day 11
Time to reach maximum observed plasma concentration (Tmax)
Measured: Pre-dose to day 11
Plasma elimination half-life (T1/2)
The time measured for the plasma concentration to decrease by one half.
Measured: Pre-dose to day 11
Secondary outcomes (3)
Amount of unchanged drug excreted in urine from zero to 24 hours post dose (Ae0-24)
Measured: From day -1 to day 11
Fraction of drug excreted unchanged in urine (fe)
Measured: From day -1 to day 11
Renal clearance
Measured: From day -1 to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start22 Jul 2025
- Primary completion22 Dec 2025
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT07034768
- Sponsor's protocol ID
- EDG-7500-105
- Status last verified
- Aug 2025
- First submitted
- 9 Jun 2025
- Last updated
- 12 Mar 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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part, Open-Label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of EDG-7500 in Participants With Impaired and Normal Renal Function
- ClinicalTrials.gov ID
- NCT07034768
- Acronym / sponsor ID
- EDG-7500-105
- Conditions
- Renal Impairments
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Edgewise Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 24 Jun 2025 (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 kidney function impairment versus participants with normal kidney function. The safety of EDG-7500 in participants with different levels of kidney function impairment will also be evaluated in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Drug: EDG-7500 |
| Severe Renal Impairment | Experimental | Drug: EDG-7500 |
| Moderate Renal Impairment | Experimental | Drug: EDG-7500 |
| Mild Renal Impairment | Experimental | Drug: EDG-7500This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- All Participants
- Adult, male or female, 18-75 years of age, inclusive
- Female and male participants must follow protocol-specified contraception guidance
- Continuous non-smoker or light smoker (≤ 5 cigarettes per day or equivalent) for at least 3 months prior to dosing
- BMI ≥ 18.0 and ≤ 40.0 kg/m2 at the screening visit.
Key exclusion criteria (14 listed)
- All Participants
- History or presence of alcohol or drug abuse within the past 2 years prior to dosing.
- Female participant with a positive pregnancy test at the screening visit or at check-in or who is lactating.
- Positive urine or breath alcohol results. Unable to refrain from or anticipates the use of any drugs.
- Positive results for HIV, HBsAg, or HCV.
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 Volunteers, Mild Renal Impairment, Moderate Renal Impairment, Severe Renal Impairment |
Primary outcome
Area under the curve from time zero to last quantifiable concentration (AUC0-last)
Time frame: Pre-dose to day 11
Area under the plasma concentration time-curve from zero to the last measured concentration (AUC0-last)
Area under the curve from time zero to extrapolated infinite time (AUC0-inf)
Time frame: Pre-dose to day 11
Area under the plasma concentration time-curve from zero to extrapolated infinite time (AUC0-inf)
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose to day 11
Observed plasma concentration at the end of the dosing interval (C24)
Time frame: Pre-dose to day 11
Time to reach maximum observed plasma concentration (Tmax)
Time frame: Pre-dose to day 11
Plasma elimination half-life (T1/2)
Time frame: Pre-dose to day 11
The time measured for the plasma concentration to decrease by one half.
3 secondary outcomes
Amount of unchanged drug excreted in urine from zero to 24 hours post dose (Ae0-24)
Time frame: From day -1 to day 11
Fraction of drug excreted unchanged in urine (fe)
Time frame: From day -1 to day 11
Renal clearance
Time frame: From day -1 to day 11
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 12 Mar 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 Renal Impairments, 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 22 inclusion and 14 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 12 Mar 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 curve from time zero to last quantifiable concentration (AUC0-last) (time frame: Pre-dose to day 11). The study lists 6 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 12 Mar 2026.