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

NCT06738836 | Completed Phase 1 FDA Drug

• 1 other identifier: EDG-7500-104
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 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. 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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)

Study Arms (1)

Human AME

EXPERIMENTAL

Drug: [14C]-EDG-7500

Interventions

[14C]-EDG-7500 DRUG

Oral liquid suspension

Human AME

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• is documented to be surgically sterile (i.e., successfully vasectomized); or
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (1)

Pharmaron Clinical Pharmacology Center, Inc.

Baltimore, Maryland, 21201, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 18, 2024
• Study Start: December 3, 2024
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

US (1)