Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers

Overseen By Edgewise Therapeutics, Inc.

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Edgewise Therapeutics, Inc.

Disqualifiers: Metabolic, Cardiovascular, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called EDG-5506 in healthy male volunteers to see how it moves through and is processed by the body. Researchers will measure the drug in blood, urine, and feces to understand its absorption and elimination.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy volunteers, it is likely that participants should not be on any regular medications.

Research Team

Sam Collins, MBBS, PhD

Principal Investigator

Edgewise Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

Males of any race between 18 and 55 years of age

Body mass index between 18.0 and 32.0 kg/m2 and total body weight greater than or equal to 50 kg

Good health determined by medical history, electrocardiogram, vital signs measurements, and clinical laboratory evaluations

Exclusion Criteria

Participation in more than 3 radiolabeled drug studies in the last 12 months

Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in

You have a history of a significant medical condition or currently have symptoms of a medical condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4-6 weeks

Part A - Treatment

Evaluation of absorption, metabolism, excretion, and pharmacokinetics of a single oral dose of radiolabeled EDG-5506

30-36 days

Confined to study site

Part B - Treatment

Evaluation of bioavailability of a single oral dose of EDG-5506 followed by a single intravenous dose of radiolabeled EDG-5506

8 days

Confined to study site

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EDG-5506

Participant Groups

Group I: Part B - aBA Experimental Treatment 2 Interventions

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

Group II: Part A - AME Experimental Treatment 1 Intervention

Evaluation of absorption, metabolism, excretion and pharmacokinetics of a single oral dose of radiolabeled EDG-5506 in healthy male volunteers

Who Is Running the Clinical Trial?

Edgewise Therapeutics, Inc.

Lead Sponsor

Trials

13

Recruited

1,000+