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

Phase 1

Recruiting

• Conditions: Renal Impairments
• Interventions: Drug: EDG-7500

• Registration Number: NCT07034768
• Lead Sponsor: Edgewise Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06-01
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-24
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

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.

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

Exclusion Criteria

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	EDG-7500	-
Mild Renal Impairment	EDG-7500	This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment
Severe Renal Impairment	EDG-7500	-
Moderate Renal Impairment	EDG-7500	-

Primary Outcome Measures

Name	Time	Method
Area under the curve from time zero to last quantifiable concentration (AUC0-last)	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)	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)	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)	Pre-dose to day 11	The time measured for the plasma concentration to decrease by one half.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

The University of Miami Division of Clinical Pharmacology; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States