Part A - AME for Musculoskeletal Disorder

Phase 1

Waitlist Available

Research Sponsored by Edgewise Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called EDG-5506 in healthy male volunteers to see how it moves through and is processed by the body. Researchers will measure the drug in blood, urine, and feces to understand its absorption and elimination.

Eligible Conditions

Musculoskeletal Disorder
Neuromuscular Diseases
Acute Myeloid Leukemia
Neutral Lipid Storage Disease
Musculoskeletal Disorders
Inclusion Body Myopathy
Disuse Atrophy
Permanent Neurological Damage
Healthy Subjects
Muscular Dystrophy
Genetic Diseases
Neuromuscular Disease
Nervous System Disorders
Muscular Disorders
Genetic Disorders

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B - aBAExperimental Treatment2 Interventions

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

Group II: Part A - AMEExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

EDG-5506 Tablet

2023

Completed Phase 1

~20

Radiolabeled EDG-5506 Suspension

2023