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

Sponsor
Edgewise Therapeutics, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05492734
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
7
Anticipated Duration (Days)
43.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study to Assess the Feasibility of Non-invasive Dried Blood Sampling for Assessment of EDG-5506 Concentrations
Anticipated Study Start Date :
Aug 12, 2022
Anticipated Primary Completion Date :
Aug 19, 2022
Anticipated Study Completion Date :
Aug 19, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

Drug: EDG-5506

Drug: EDG-5506
single oral dose

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling [7 days]

  3. Time of maximum concentration (Tmax) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling [7 days]

Secondary Outcome Measures

  1. Area under the concentration-time curve (AUC0-24, AUC0-26, AUC0-144 and AUC0-t) measurements for EDG-5506 in plasma. [7 days]

  2. Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in plasma. [7 days]

  3. Time of maximum concentration (Tmax) measurements for EDG-5506 in plasma. [7 days]

  4. Incidence of treatment-emergent adverse events [7 days]

  5. Incidence of abnormal clinical laboratory test results [7 days]

  6. Incidence of abnormal vital signs [7 days]

  7. Incidence of abnormal electrocardiograms (ECGs) [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Celerion, Inc. Lincoln Nebraska United States 68502

Sponsors and Collaborators

  • Edgewise Therapeutics, Inc.

Investigators

  • Study Chair: Sam Collins, MBBS, PhD, Edgewise Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Edgewise Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05492734
Other Study ID Numbers:
  • EDG-5506-104
First Posted:
Aug 8, 2022
Last Update Posted:
Aug 8, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Edgewise Therapeutics, Inc.
Healthy Volunteers
Additional relevant MeSH terms:
Muscular Dystrophies

Study Results

No Results Posted as of Aug 8, 2022