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

NCT05730842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-04-18

No results posted yet for this study

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

Interventions

DRUG

EDG-5506 Tablet

Single Oral Dose - Tablet

DRUG

Radiolabeled EDG-5506 Suspension

Single Oral Dose

DRUG

Radiolabeled EDG-5506 Intravenous

Single Intravenous Dose

Sponsors & Collaborators

  • Edgewise Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sam Collins, MBBS, PhD · Edgewise Therapeutics, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2023-04-06
Completion
2023-04-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05730842 on ClinicalTrials.gov