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

• Status: Enrolling by invitation
• Trial end date: 2022-08-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Edgewise Therapeutics, Inc.

Criteria

Inclusion Criteria:

1. Healthy, adult, males or females, aged 19-55 years (inclusive) at the Screening visit.

2. 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.

3. Non-smoker and must not have used any tobacco products within 3 months prior to the Screening visit.

4. Body weight greater than 50 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive at the Screening visit.

5. 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.

Exclusion Criteria:

1. 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.

2. Female participants with a positive pregnancy test at the screening visit or are lactating.

3. Poor venous access and/or cannot tolerate venipuncture.

4. 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.

5. Participation in any other investigational drug study within 30 days prior to dosing.