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

Edgewise Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Renal Impairments

Treatments: Drug: EDG-7500

Study type: Interventional

Funder types: Industry

Identifiers

NCT07034768

EDG-7500-105

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Healthy Volunteers

Experimental group

Treatment:

Drug: EDG-7500

Severe Renal Impairment

Experimental group

Treatment:

Drug: EDG-7500

Moderate Renal Impairment

Experimental group

Treatment:

Drug: EDG-7500

Mild Renal Impairment

Experimental group

Description:

This arm will only be conducted if deemed necessary based on data in participants with moderate and severe renal impairment

Treatment:

Drug: EDG-7500