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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: EDG-5506 Tablet
* Drug: Radiolabeled EDG-5506 Suspension
* Drug: Radiolabeled EDG-5506 Intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A - AME<br>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<br>* Single Oral Dose<br>|
| Experimental: Part B - aBA<br>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<br>* Single Oral Dose - Tablet<br>Drug: Radiolabeled EDG-5506 Intravenous<br>* Single Intravenous Dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer