Genetic Diseases, Inborn, Healthy Volunteer, Muscular Diseases, Muscular Disorders, Atrophic, Muscular Dystrophies, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases
Conditions
Keywords
Healthy Volunteer
Brief 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.
Detailed description
This is a Phase 1 2-part, single-center, open-label study. Up to 15 (8 in Part A and 7 in Part B) healthy male subjects will be enrolled in the study. Part A: Potential subjects will be screened to assess eligibility within 28 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until at least Day 30. On Day 1, subjects will receive a single oral suspension. Blood, urine and feces samples will be collected for determination of EDG-5506 concentration, total radioactivity, and metabolite profiling and identification. Between Day 30 and Day 36, subjects will be discharged. Part B: Potential subjects will be screened to assess their eligibility within 42 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until Day 8. On Day 1, subjects will receive a single oral dose of EDG-5506 in the fasted state followed 2 hours later by a single dose of radiolabeled EDG-5506. Subjects will be discharged from the study site on Day 8. Blood samples will be collected.
Interventions
DRUGEDG-5506 Tablet
Single Oral Dose - Tablet
DRUGRadiolabeled EDG-5506 Suspension
Single Oral Dose
DRUGRadiolabeled EDG-5506 Intravenous
Single Intravenous Dose
Sponsors
Edgewise Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. For both Part A and Part B, males, of any race, between 18 and 55 years of age, inclusive. 2. For both Part A and Part B, a body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight greater than or equal to 50 kg. 3. In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram, vital signs measurements, and clinical laboratory evaluations at screening and check-in.
Exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, immunological, or psychiatric disorder, as determined by the investigator (or designee). 2. Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to dosing. 3. Participation in more than 3 radiolabeled drug studies in the last 12 months. 4. Poor peripheral venous access. 5. Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute bioavailability of EDG-5506 as measured by Fabs | Up to 9 days |
| The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine | Up to 37 days |
| The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces | Up to 37 days |
| Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 | Up to 37 days |
| Characterization of EDG-5506 as measured by urinary recovery (fet1-t2) | Up to 37 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of abnormal clinical laboratory test results | Up to 37 days |
| Incidence of abnormal electrocardiograms (ECGs) | Up to 37 days |
| Distribution of total radioactivity into blood cells as measured by whole blood to plasma concentration ratio | Up to 37 days |
| Incidence of treatment-emergent adverse events | Up to 37 days |
Countries
United States
Outcome results
None listed