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

Phase 1

Completed

• Conditions: Genetic Diseases, Inborn; Muscular Dystrophies; Healthy Volunteer; Muscular Disorders, Atrophic; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases; Nervous System Diseases
• Interventions: Drug: Radiolabeled EDG-5506 Suspension; Drug: EDG-5506 Tablet; Drug: Radiolabeled EDG-5506 Intravenous

• Registration Number: NCT05730842
• Lead Sponsor: Edgewise Therapeutics, Inc.

Brief 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.

Study Timeline

• Study Start: 2023-01-12
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-07
• Study First Posted: 2023-02-16
• Status Verified: 2023-04
• Primary Completion: 2023-04-06
• Study Completion: 2023-04-06
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

1. For both Part A and Part B, males, of any race, between 18 and 55 years of age, inclusive.
2. 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.
3. 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.

Exclusion Criteria

1. 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).
2. 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.
3. Participation in more than 3 radiolabeled drug studies in the last 12 months.
4. Poor peripheral venous access.
5. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part A - AME	Radiolabeled EDG-5506 Suspension	Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers
Part B - aBA	Radiolabeled EDG-5506 Intravenous	Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506 in healthy male volunteers
Part B - aBA	EDG-5506 Tablet	Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506 in healthy male volunteers

Primary Outcome Measures

Name	Time	Method
The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine	Up to 37 days
Absolute bioavailability of EDG-5506 as measured by Fabs	Up to 9 days
The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces	Up to 37 days
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506	Up to 37 days
Characterization of EDG-5506 as measured by urinary recovery (fet1-t2)	Up to 37 days

Secondary Outcome Measures

Name	Time	Method
Incidence of abnormal clinical laboratory test results	Up to 37 days
Incidence of treatment-emergent adverse events	Up to 37 days
Incidence of abnormal electrocardiograms (ECGs)	Up to 37 days
Distribution of total radioactivity into blood cells as measured by whole blood to plasma concentration ratio	Up to 37 days

Trial Locations

Locations (1)

Labcorp Clinical Research Unit, Inc.; 🇺🇸 Madison, Wisconsin, United States