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

NCT05492734 | Completed Phase 1 FDA Drug

• 1 other identifier: EDG-5506-104
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscular Dystrophies

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Difference in area under the concentration-time curve (AUC0-24, AUC0-26, AUC0-144 and AUC0-t) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling

  7 days

• Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling

  7 days

• Time of maximum concentration (Tmax) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling

  7 days

Secondary Outcomes (7)

• Area under the concentration-time curve (AUC0-24, AUC0-26, AUC0-144 and AUC0-t) measurements for EDG-5506 in plasma.

  7 days

• Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in plasma.

  7 days

• Time of maximum concentration (Tmax) measurements for EDG-5506 in plasma.

  7 days

• Incidence of treatment-emergent adverse events

  7 days

• Incidence of abnormal clinical laboratory test results

  7 days

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: EDG-5506

Drug: EDG-5506

Interventions

EDG-5506 DRUG

single oral dose

Treatment

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, adult, males or females, aged 19-55 years (inclusive) at the Screening visit.
• Females must be of non-childbearing potential. Males with female partners must use a medically accepted contraceptive regimen or abstain from sexual intercourse for 90 days after dosing.
• Non-smoker and must not have used any tobacco products within 3 months prior to the Screening visit.
• Body weight greater than 50 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive at the Screening visit.
• Medically healthy with no clinically significant findings for oculofacial and proximal limb strength assessments and swallowing function assessment, medical history, physical examination, laboratory profiles, vital signs, and ECGs.

You may not qualify if:

• History of, or physical examination findings indicating clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases that, in the opinion of the PI, would render the subject being unsuitable for the study.
• Female participants with a positive pregnancy test at the screening visit or are lactating.
• Poor venous access and/or cannot tolerate venipuncture.
• Unable to refrain from or anticipates the use of any drugs (including prescription and non-prescription medications, herbal remedies, vitamin supplements, or grapefruit/Seville orange containing products) beginning 14 days prior to dosing. Any drugs known to be moderate or strong inducers of CYP3A4 enzymes cannot be used within 28 days prior to dosing.
• Participation in any other investigational drug study within 30 days prior to dosing.

Sponsors & Collaborators

• Edgewise Therapeutics, Inc.: lead

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Muscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sam Collins, MBBS, PhD

  Edgewise Therapeutics, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 8, 2022
• Study Start: August 12, 2022
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: September 2, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)