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Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers
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
- Cardiomyopathy
- 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
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
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
12 Previous Clinical Trials
902 Total Patients Enrolled
Sam Collins, MBBS, PhDStudy ChairEdgewise Therapeutics, Inc.
6 Previous Clinical Trials
512 Total Patients Enrolled