Clinical trial NCT05730842: Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Keywords: Healthy Volunteer
Lead sponsor: Edgewise Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine
timeFrame: Up to 37 days
measure: The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces
timeFrame: Up to 37 days
measure: Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506
timeFrame: Up to 37 days
measure: Characterization of EDG-5506 as measured by urinary recovery (fet1-t2)
timeFrame: Up to 37 days
measure: Absolute bioavailability of EDG-5506 as measured by Fabs
timeFrame: Up to 9 days
Secondary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: Up to 37 days
measure: Incidence of abnormal clinical laboratory test results
timeFrame: Up to 37 days
measure: Incidence of abnormal electrocardiograms (ECGs)
timeFrame: Up to 37 days
measure: Distribution of total radioactivity into blood cells as measured by whole blood to plasma concentration ratio
timeFrame: Up to 37 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Labcorp Clinical Research Unit, Inc.
state: Wisconsin
Study officials:
affiliation: Edgewise Therapeutics, Inc.
name: Sam Collins, MBBS, PhD
role: STUDY_CHAIR
References: