A Study to Evaluate EDG-7500 in People With Renal Impairment

NCT07034768 | Completed Phase 1 FDA Drug

• 1 other identifier: EDG-7500-105
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief 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. The safety of EDG-7500 in participants with different levels of kidney function impairment will also be evaluated in this study.

Conditions

Renal Impairments

Outcome Measures

Primary Outcomes (6)

• 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)

  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)

  Pre-dose to day 11

• Maximum observed plasma concentration (Cmax)

  Pre-dose to day 11

• Observed plasma concentration at the end of the dosing interval (C24)

  Pre-dose to day 11

• Time to reach maximum observed plasma concentration (Tmax)

  Pre-dose to day 11

• Plasma elimination half-life (T1/2)

  The time measured for the plasma concentration to decrease by one half.

  Pre-dose to day 11

Secondary Outcomes (3)

• Amount of unchanged drug excreted in urine from zero to 24 hours post dose (Ae0-24)

  From day -1 to day 11

• Fraction of drug excreted unchanged in urine (fe)

  From day -1 to day 11

• Renal clearance

  From day -1 to day 11

Study Arms (4)

Healthy Volunteers

EXPERIMENTAL

Drug: EDG-7500

Severe Renal Impairment

EXPERIMENTAL

Drug: EDG-7500

Moderate Renal Impairment

EXPERIMENTAL

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

Drug: EDG-7500

Interventions

EDG-7500 DRUG

Single dose of EDG-7500

Healthy Volunteers; Mild Renal Impairment; Moderate Renal Impairment; Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (2)

The University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 24, 2025
• Study Start: July 22, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 26, 2025
• Last Updated: March 12, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)