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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05730842
Other study ID # EDG-5506-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date January 12, 2023
Est. completion date April 6, 2023

Study information

Verified date April 2023
Source Edgewise Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
EDG-5506 Tablet
Single Oral Dose - Tablet
Radiolabeled EDG-5506 Suspension
Single Oral Dose
Radiolabeled EDG-5506 Intravenous
Single Intravenous Dose

Locations

Country Name City State
United States Labcorp Clinical Research Unit, Inc. Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Edgewise Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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