Skip to main content
OpenTrials
Completed

NCT Number: NCT06738836

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron Clinical Pharmacology Center, Inc.

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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.

Treatment and study plan

[14C]-EDG-7500

Drug

Oral liquid suspension

Primary outcomes

  1. Mass Balance

    Time frame: From Day -1 through study completion (up to 19 days)

  2. Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Cmax

    Time frame: From Day 1 to study completion (up to 18 days)

  3. Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Tmax

    Time frame: From Day 1 to study completion (up to 18 days)

  4. Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by T1/2

    Time frame: From Day 1 to study completion (up to 18 days)

  5. Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by AUC0-inf

    Time frame: From Day 1 to study completion (up to 18 days)

Secondary outcomes

  1. Metabolite profile

    Time frame: From Day -1 through study completion (up to 19 days)

  2. Safety as measured by occurrence of adverse events, clinical laboratory evaluations, 12-lead ECG and vital sign measurements

    Time frame: From screening through study completion (up to 54 days)

Sponsors and collaborators

Lead sponsor

Edgewise Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2024
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.