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

Primary Purpose

Healthy Volunteer, Muscular Dystrophies, Muscular Disorders, Atrophic

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EDG-5506 Tablet
Radiolabeled EDG-5506 Suspension
Radiolabeled EDG-5506 Intravenous
Sponsored by
Edgewise Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Volunteer focused on measuring Healthy Volunteer

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Labcorp Clinical Research Unit, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A - AME

Part B - aBA

Arm Description

Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2023
Last Updated
April 14, 2023
Sponsor
Edgewise Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05730842
Brief Title
Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
April 6, 2023 (Actual)
Study Completion Date
April 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edgewise Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteer, Muscular Dystrophies, Muscular Disorders, Atrophic, Muscular Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Nervous System Diseases, Genetic Diseases, Inborn
Keywords
Healthy Volunteer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A - AME
Arm Type
Experimental
Arm Description
Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers
Arm Title
Part B - aBA
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
EDG-5506 Tablet
Intervention Description
Single Oral Dose - Tablet
Intervention Type
Drug
Intervention Name(s)
Radiolabeled EDG-5506 Suspension
Intervention Description
Single Oral Dose
Intervention Type
Drug
Intervention Name(s)
Radiolabeled EDG-5506 Intravenous
Intervention Description
Single Intravenous Dose
Primary Outcome Measure Information:
Title
The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine
Time Frame
Up to 37 days
Title
The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces
Time Frame
Up to 37 days
Title
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506
Time Frame
Up to 37 days
Title
Characterization of EDG-5506 as measured by urinary recovery (fet1-t2)
Time Frame
Up to 37 days
Title
Absolute bioavailability of EDG-5506 as measured by Fabs
Time Frame
Up to 9 days
Secondary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Time Frame
Up to 37 days
Title
Incidence of abnormal clinical laboratory test results
Time Frame
Up to 37 days
Title
Incidence of abnormal electrocardiograms (ECGs)
Time Frame
Up to 37 days
Title
Distribution of total radioactivity into blood cells as measured by whole blood to plasma concentration ratio
Time Frame
Up to 37 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Collins, MBBS, PhD
Organizational Affiliation
Edgewise Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Labcorp Clinical Research Unit, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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