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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 37 days

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

Do I qualify?Apply below to find out

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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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial restricted to persons aged 55 or younger?

"To partake in this trial, volunteers must be between 18 and 55 years of age."

Answered by AI

Is there an opportunity for me to participate in this clinical examination?

"To be part of this clinical trial, a person must have diagnosed neurological disorders and an age range between 18-55. This medical study is currently looking to enrol 15 individuals in total."

Answered by AI

Is Part A - AME associated with any significant risks for patients?

"The safety of Part A - AME is assessed as a 1 due to the lack of prior research backing its efficacy and security. It currently sits in Phase 1 clinical trials."

Answered by AI

Is there currently an opportunity to take part in this research endeavor?

"As indicated on clinicaltrials.gov, this medical trial is actively enrolling volunteers—having been first posted to the website on December 1st 2023 and most recently updated February 7th 2023."

Answered by AI

How many participants are being welcomed into this trial?

"Yes, clinicaltrials.gov states that this clinical trial is currently screening applicants. This study was posted on December 1st 2023 and recently revised on February 7th 2023; with a total of 15 patients being sought from one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05730842.