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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Drug: EDG-5506 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDG-5506 | Drug | single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Collins, MBBS, PhD | Edgewise Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| ID | Term |
|---|---|
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
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| 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 |
| Incidence of abnormal vital signs | 7 days |
| Incidence of abnormal electrocardiograms (ECGs) | 7 days |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |