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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: [14C]-EDG-7500

• Registration Number: NCT06738836
• Lead Sponsor: Edgewise Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-03
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-18
• Primary Completion: 2025-01-17
• Study Completion: 2025-01-17
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human AME	[14C]-EDG-7500	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Pharmaron Clinical Pharmacology Center, Inc.; 🇺🇸 Baltimore, Maryland, United States