Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Volunteer, Muscular Dystrophies, Muscular Disorders, Atrophic, Muscular Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Nervous System Diseases, Genetic Diseases, Inborn

In brief

This is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.

Key facts

Study ID

NCT05730842

Run by

Edgewise Therapeutics, Inc.

People needed

15

Starts

2023-01-12

Expected to finish

2023-04-06

Last updated by the study team

2023-04-18

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• For both Part A and Part B, males, of any race, between 18 and 55 years of age, inclusive.
• For both Part A and Part B, a body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight greater than or equal to 50 kg.
• In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram, vital signs measurements, and clinical laboratory evaluations at screening and check-in.

You may not qualify if…

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, immunological, or psychiatric disorder, as determined by the investigator (or designee).
• Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to dosing.
• Participation in more than 3 radiolabeled drug studies in the last 12 months.
• Poor peripheral venous access.
• Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.

Where it is running

• Labcorp Clinical Research Unit, Inc. — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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