A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling

Status Completed

Clinical Trial Summary

This is a Phase I, open-label, single-dose, 1-period study to compare EDG-5506 concentrations measured from venous and capillary blood sampling in healthy adult subjects. EDG-5506 is an investigational product designed to selectively modulate a fast skeletal muscle motor protein called myosin that is part of the contraction machinery of the damage-prone muscle fibers.

Clinical Trial Description

Ten (10) healthy, adult male and female (of non-childbearing potential only) participants will be enrolled in the single-site study. Participants will receive a single oral dose of EDG-5506 on Day 1. Serial blood sampling will be collected pre-dose and up to 26 hours post-dose using venous blood sampling by venipuncture and capillary blood sampling by a capillary blood self-sampling device. On Day 3, participants will self-collect a capillary blood sample at home. The final on-site visit will be on Day 7 when a last blood sample will be collected using venous blood sampling by venipuncture and capillary blood sampling by a capillary blood self-sampling device. ;

Study Design

Related Conditions & MeSH terms

Muscular Dystrophies

Clinical Trial Details

NCT number	NCT05492734
Study type	Interventional
Source	Edgewise Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 1
Start date	August 12, 2022
Completion date	August 19, 2022

View Details

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