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

NCT05730842 | Completed Phase 1 FDA Drug

• 1 other identifier: EDG-5506-103
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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

Study Arms (2)

Part A - AME

EXPERIMENTAL

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

Part B - aBA

EXPERIMENTAL

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; Drug: Radiolabeled EDG-5506 Intravenous

Interventions

EDG-5506 Tablet DRUG

Single Oral Dose - Tablet

Part B - aBA

Radiolabeled EDG-5506 Suspension DRUG

Single Oral Dose

Part A - AME

Radiolabeled EDG-5506 Intravenous DRUG

Single Intravenous Dose

Part B - aBA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (1)

Labcorp Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sam Collins, MBBS, PhD

  Edgewise Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: January 12, 2023
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)