RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-06

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07034768

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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. * 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	* 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. * History or presence of renal artery stenosis. * Renal transplant or nephrectomy in ≤ 5 years. * Diabetes confirmed with HbA1c \> 8.5%.

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.
* 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

* 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.
* History or presence of renal artery stenosis.
* Renal transplant or nephrectomy in ≤ 5 years.
* Diabetes confirmed with HbA1c \> 8.5%.

Contacts and Locations

Study Contact

Edgewise Therapeutics, Inc.

CONTACT

720-262-7002

cardiacstudies@edgewisetx.com

Study Locations (Sites)

The University of Miami Division of Clinical Pharmacology

Miami, Florida, 33136

United States

Orlando Clinical Research Center

Orlando, Florida, 32809

United States

Collaborators and Investigators

Sponsor: Edgewise Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2025-06

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Renal Impairments