drugset / Trial / NCT05730842

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

NCT05730842

Phase 1 Completed 15 enrolled Edgewise Therapeutics, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-01-12
Primary completion
2023-04-06
Completion
2023-04-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Sevasemten Small molecule Oral