A Phase 1, Open-label Study in Healthy Male Subjects of the Absorption, Metabolism, Excretion, and Pharmacokinetics of EDG-5506 and an Absolute Bioavailability Study Using Radiolabeled EDG-5506
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Edgewise Therapeutics, Inc.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •For both Part A and Part B, males, of any race, between 18 and 55 years of age, inclusive.
- •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.
- •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
- •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).
- •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.
- •Participation in more than 3 radiolabeled drug studies in the last 12 months.
- •Poor peripheral venous access.
- •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.
Arms & Interventions
Part A - AME
Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers
Intervention: Radiolabeled EDG-5506 Suspension (Drug)
Part B - aBA
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
Intervention: EDG-5506 Tablet (Drug)
Part B - aBA
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
Intervention: Radiolabeled EDG-5506 Intravenous (Drug)
Outcomes
Primary Outcomes
The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine
Time Frame: Up to 37 days
Absolute bioavailability of EDG-5506 as measured by Fabs
Time Frame: Up to 9 days
The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces
Time Frame: Up to 37 days
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506
Time Frame: Up to 37 days
Characterization of EDG-5506 as measured by urinary recovery (fet1-t2)
Time Frame: Up to 37 days
Secondary Outcomes
- Incidence of abnormal clinical laboratory test results(Up to 37 days)
- Incidence of treatment-emergent adverse events(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)