Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-26 @ 5:45 PM
Study NCT ID:
NCT05492734
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2022-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling
Sponsor:
Edgewise Therapeutics, Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Study to Assess the Feasibility of Non-invasive Dried Blood Sampling for Assessment of EDG-5506 Concentrations
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: