Healthy Volunteer
Conditions
Brief summary
The purpose of this study is to: 1. Assess the mass balance (i.e., the cumulative elimination of 14C-related material in urine and feces, compared to the administered amount of radioactive isotope) of \[14C\]-EDG-7500 following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects. 2. Characterize the pharmacokinetics of EDG-7500 in plasma and of 14C-related material in whole blood, plasma, urine and feces following a single oral dose of EDG-7500 containing a radioactive tracer, in healthy, adult male subjects.
Interventions
DRUG[14C]-EDG-7500
Oral liquid suspension
Sponsors
Edgewise Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Biological males ≥ 18.0 and \< 55.0 years of age at time of providing Informed Consent. * Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight ≥ 55.0 kg and ≤ 100.0 kg at Screening. * Subjects with female sexual partner(s) of reproductive potential may be enrolled if the male: 1. is documented to be surgically sterile (i.e., successfully vasectomized); or 2. agrees to use double-barrier contraception for at least 3 months after receiving study drug and agrees to refrain from sperm donation from the time of Screening through 3 months post dose. * Negative for hepatitis B surface antigen, hepatitis C virus antibody and human immunodeficiency virus antibody and antigen. * Non-smoker Key
Exclusion criteria
* Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG or laboratory tests at Screening, Admission or predose on Day 1. * Any history of serious allergic/hypersensitivity reactions. * History or presence of alcohol or drug abuse within 2 years prior to Screening. * Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void. Usual habit of \< 1 or \> 3 bowel movements per day. * Exposure to radiation for therapeutic or diagnostic reasons (except dental X rays and plain X rays of the thorax and bony skeleton) within the past 12 months . * Participation in another clinical study in which a \[14C\]-labeled drug was administered within 1 year prior to Admission. * QTcF interval (QT interval corrected for heart rate per Fridericia's formula) \> 450 msec at Screening, Admission or predose on Day 1. Personal and family history of long QT syndrome or unexplained sudden death in a first-degree relative under 50 years of age. * Glomerular filtration rate (GFR) \< 80 mL/min/1.73 m2 * Loss or donation of blood (approximately 500 mL or greater) within 60 days prior to study drug administration on Day 1; donation of bone marrow or peripheral stem cells within 90 days prior to study drug administration on Day 1; or donation of plasma within 30 days prior to study drug administration on Day 1. Additional protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Cmax | From Day 1 to study completion (up to 18 days) |
| Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by T1/2 | From Day 1 to study completion (up to 18 days) |
| Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by AUC0-inf | From Day 1 to study completion (up to 18 days) |
| Mass Balance | From Day -1 through study completion (up to 19 days) |
| Pharmacokinetics of EDG-7500 in plasma and 14C total radioactivity in plasma and whole blood as measured by Tmax | From Day 1 to study completion (up to 18 days) |
Secondary
| Measure | Time frame |
|---|---|
| Safety as measured by occurrence of adverse events, clinical laboratory evaluations, 12-lead ECG and vital sign measurements | From screening through study completion (up to 54 days) |
| Metabolite profile | From Day -1 through study completion (up to 19 days) |
Countries
United States
Outcome results
None listed