A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500

An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EDG-7500 Following Single-Dose Oral Administration

The purpose of this study is to:

1. Assess the mass balance (i.e., the cumulative elimination of 14C-related material in urine and feces, compared to the administered amount of radioactive isotope) of [14C]-EDG-7500 following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
2. Characterize the pharmacokinetics of EDG-7500 in plasma and of 14C-related material in whole blood, plasma, urine and feces following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: [14C]-EDG-7500

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron Clinical Pharmacology Center, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Biological males ≥ 18.0 and < 55.0 years of age at time of providing Informed Consent.
• Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening.

• Subjects with female sexual partner(s) of reproductive potential may be enrolled if the male:

  1. is documented to be surgically sterile (i.e., successfully vasectomized); or
  2. agrees to use double-barrier contraception for at least 3 months after receiving study drug and agrees to refrain from sperm donation from the time of Screening through 3 months post dose.
• Negative for hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody and antigen.
• Non-smoker

Key Exclusion Criteria:

• Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG or laboratory tests at Screening, Admission or predose on Day 1.
• Any history of serious allergic/hypersensitivity reactions.
• History or presence of alcohol or drug abuse within 2 years prior to Screening.
• Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void. Usual habit of < 1 or > 3 bowel movements per day.
• Exposure to radiation for therapeutic or diagnostic reasons (except dental X rays and plain X rays of the thorax and bony skeleton) within the past 12 months .
• Participation in another clinical study in which a [14C]-labeled drug was administered within 1 year prior to Admission.
• QTcF interval (QT interval corrected for heart rate per Fridericia's formula) > 450 msec at Screening, Admission or predose on Day 1. Personal and family history of long QT syndrome or unexplained sudden death in a first-degree relative under 50 years of age.
• Glomerular filtration rate (GFR) < 80 mL/min/1.73 m2
• Loss or donation of blood (approximately 500 mL or greater) within 60 days prior to study drug administration on Day 1; donation of bone marrow or peripheral stem cells within 90 days prior to study drug administration on Day 1; or donation of plasma within 30 days prior to study drug administration on Day 1.

Additional protocol defined inclusion/exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Human AME	Drug: [14C]-EDG-7500; Oral liquid suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mass Balance	From Day -1 through study completion (up to 19 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Cmax	From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Tmax	From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by T1/2	From Day 1 to study completion (up to 18 days)
Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by AUC0-inf	From Day 1 to study completion (up to 18 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Metabolite profile	From Day -1 through study completion (up to 19 days)
Safety as measured by occurrence of adverse events, clinical laboratory evaluations, 12-lead ECG and vital sign measurements	From screening through study completion (up to 54 days)

Collaborators and Investigators

• Sponsor: Edgewise Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Actual): January 17, 2025
• Study Completion (Actual): January 17, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EDG-7500-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No