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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Labcorp Clinical Research Unit, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A - AME; Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers	Drug: Radiolabeled EDG-5506 Suspension; Single Oral Dose
Experimental: Part B - aBA; 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	Drug: EDG-5506 Tablet; Single Oral Dose - Tablet; Drug: Radiolabeled EDG-5506 Intravenous; Single Intravenous Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine	Up to 37 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
Absolute bioavailability of EDG-5506 as measured by Fabs	Up to 9 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events	Up to 37 days
Incidence of abnormal clinical laboratory test results	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

Collaborators and Investigators

• Sponsor: Edgewise Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): April 6, 2023
• Study Completion (Actual): April 6, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Volunteer
• Additional Relevant MeSH Terms: Muscular Dystrophies; Nervous System Diseases; Musculoskeletal Diseases; Muscular Diseases; Genetic Diseases, Inborn; Neuromuscular Diseases; Muscular Disorders, Atrophic
• Other Study ID Numbers: EDG-5506-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No