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Part A - AME for Muscular Dystrophy

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 37 days
Awards & highlights

Study Summary

This trial will study how one dose of a drug is absorbed, used, and excreted in healthy male volunteers.

Eligible Conditions
  • Muscular Dystrophy
  • Healthy Subjects
  • Musculoskeletal Disorders
  • Neuromuscular Disease
  • Nervous System Disorders
  • Muscular Disorders
  • Genetic Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 37 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 37 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute bioavailability of EDG-5506 as measured by Fabs
Characterization of EDG-5506 as measured by urinary recovery (fet1-t2)
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506
+2 more
Secondary outcome measures
Distribution of total radioactivity into blood cells as measured by whole blood to plasma concentration ratio
Incidence of abnormal clinical laboratory test results
Incidence of abnormal electrocardiograms (ECGs)
+1 more

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
Completed Phase 1
~20
Radiolabeled EDG-5506 Intravenous
2023
Completed Phase 1
~20

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Edgewise Therapeutics, Inc.Lead Sponsor
11 Previous Clinical Trials
851 Total Patients Enrolled
Sam Collins, MBBS, PhDStudy ChairEdgewise Therapeutics, Inc.
6 Previous Clinical Trials
470 Total Patients Enrolled
~6 spots leftby Jun 2025
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