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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05730842
• Other study ID #: EDG-5506-103
• Status: Completed
• Phase: Phase 1
• Start date: January 12, 2023
• Est. completion date: April 6, 2023

Study information

• Verified date: April 2023
• Source: Edgewise Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 6, 2023
• Est. primary completion date: April 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• EDG-5506 Tablet
Single Oral Dose - Tablet
• Radiolabeled EDG-5506 Suspension
Single Oral Dose
• Radiolabeled EDG-5506 Intravenous
Single Intravenous Dose

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit, Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Edgewise Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine		Up to 37 days
Primary	The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces		Up to 37 days
Primary	Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506		Up to 37 days
Primary	Characterization of EDG-5506 as measured by urinary recovery (fet1-t2)		Up to 37 days
Primary	Absolute bioavailability of EDG-5506 as measured by Fabs		Up to 9 days
Secondary	Incidence of treatment-emergent adverse events		Up to 37 days
Secondary	Incidence of abnormal clinical laboratory test results		Up to 37 days
Secondary	Incidence of abnormal electrocardiograms (ECGs)		Up to 37 days
Secondary	Distribution of total radioactivity into blood cells as measured by whole blood to plasma concentration ratio		Up to 37 days