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

Primary Purpose

Muscular Dystrophies

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EDG-5506
Sponsored by
Edgewise Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophies focused on measuring Healthy Volunteers

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Celerion, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Drug: EDG-5506

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Area under the concentration-time curve (AUC0-24, AUC0-26, AUC0-144 and AUC0-t) measurements for EDG-5506 in plasma.
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in plasma.
Time of maximum concentration (Tmax) measurements for EDG-5506 in plasma.
Incidence of treatment-emergent adverse events
Incidence of abnormal clinical laboratory test results
Incidence of abnormal vital signs
Incidence of abnormal electrocardiograms (ECGs)

Full Information

First Posted
August 5, 2022
Last Updated
September 1, 2022
Sponsor
Edgewise Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05492734
Brief Title
A Study to Assess the Feasibility of Non-invasive Dried Blood Sampling
Official Title
A Phase 1 Study to Assess the Feasibility of Non-invasive Dried Blood Sampling for Assessment of EDG-5506 Concentrations
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2022 (Actual)
Primary Completion Date
August 19, 2022 (Actual)
Study Completion Date
August 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edgewise Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophies
Keywords
Healthy Volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Drug: EDG-5506
Intervention Type
Drug
Intervention Name(s)
EDG-5506
Intervention Description
single oral dose
Primary Outcome Measure Information:
Title
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
Time Frame
7 days
Title
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling
Time Frame
7 days
Title
Time of maximum concentration (Tmax) measurements for EDG-5506 in blood collected by capillary blood self-sampling versus venous blood sampling
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Area under the concentration-time curve (AUC0-24, AUC0-26, AUC0-144 and AUC0-t) measurements for EDG-5506 in plasma.
Time Frame
7 days
Title
Plasma maximum measured drug concentration (Cmax) measurements for EDG-5506 in plasma.
Time Frame
7 days
Title
Time of maximum concentration (Tmax) measurements for EDG-5506 in plasma.
Time Frame
7 days
Title
Incidence of treatment-emergent adverse events
Time Frame
7 days
Title
Incidence of abnormal clinical laboratory test results
Time Frame
7 days
Title
Incidence of abnormal vital signs
Time Frame
7 days
Title
Incidence of abnormal electrocardiograms (ECGs)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Collins, MBBS, PhD
Organizational Affiliation
Edgewise Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Celerion, Inc.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.edgewisetx.com
Description
Sponsor Website

Learn more about this trial

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

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