NCT05730842

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

A Phase 1, Open-label Study in Healthy Male Subjects of the Absorption, Metabolism, Excretion, and Pharmacokinetics of EDG-5506 and an Absolute Bioavailability Study Using Radiolabeled EDG-5506

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Edgewise Therapeutics, Inc. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

This is a Phase 1 2-part, single-center, open-label study. Up to 15 (8 in Part A and 7 in Part B) healthy male subjects will be enrolled in the study. Part A: Potential subjects will be screened to assess eligibility within 28 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until at least Day 30. On Day 1, subjects will receive a single oral suspension. Blood, urine and feces samples will be collected for determination of EDG-5506 concentration, total radioactivity, and metabolite profiling and identification. Between Day 30 and Day 36, subjects will be discharged. Part B: Potential subjects will be screened to assess their eligibility within 42 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until Day 8. On Day 1, subjects will receive a single oral dose of EDG-5506 in the fasted state followed 2 hours later by a single dose of radiolabeled EDG-5506. Subjects will be discharged from the study site on Day 8. Blood samples will be collected.

Conditions

• Healthy Volunteer
• Muscular Dystrophies
• Muscular Disorders, Atrophic
• Muscular Diseases
• Musculoskeletal Diseases
• Neuromuscular Diseases
• Nervous System Diseases
• Genetic Diseases, Inborn

Interventions

Type	Name	Description
DRUG	EDG-5506 Tablet	Single Oral Dose - Tablet
DRUG	Radiolabeled EDG-5506 Suspension	Single Oral Dose
DRUG	Radiolabeled EDG-5506 Intravenous	Single Intravenous Dose

Timeline

• Start date: 2023-01-12
• Primary completion: 2023-04-06
• Completion: 2023-04-06
• First posted: 2023-02-16
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study