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

Sponsor

Edgewise Therapeutics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05730842

Collaborator

(none)

Enrollment

Location

Arms

1.6

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer Muscular Dystrophies Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn	Drug: EDG-5506 Tablet Drug: Radiolabeled EDG-5506 Suspension Drug: Radiolabeled EDG-5506 Intravenous	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 12, 2023

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.