Healthy Volunteer Clinical Trial
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
Verified date | April 2023 |
Source | Edgewise Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | April 6, 2023 |
Est. primary completion date | April 6, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Labcorp Clinical Research Unit, Inc. | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Edgewise Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The mass balance of EDG-5506 as measured by the total radioactivity recovered in urine | Up to 37 days | ||
Primary | The mass balance of EDG-5506 as measured by the total radioactivity recovered in feces | Up to 37 days | ||
Primary | Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 | Up to 37 days | ||
Primary | Characterization of EDG-5506 as measured by urinary recovery (fet1-t2) | Up to 37 days | ||
Primary | Absolute bioavailability of EDG-5506 as measured by Fabs | Up to 9 days | ||
Secondary | Incidence of treatment-emergent adverse events | Up to 37 days | ||
Secondary | Incidence of abnormal clinical laboratory test results | Up to 37 days | ||
Secondary | Incidence of abnormal electrocardiograms (ECGs) | Up to 37 days | ||
Secondary | Distribution of total radioactivity into blood cells as measured by whole blood to plasma concentration ratio | Up to 37 days |
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