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This study is being conducted in order to understand the safety and effects of different doses of EDG-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (oHCM) and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy (nHCM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: EDG-7500 Single Dose | Experimental |
| |
| Part B: EDG-7500 Multiple Dose in Adults with Obstructive Hypertrophic Cardiomyopathy | Experimental | EDG-7500 once daily for up to 28 days. |
|
| Part C: EDG-7500 Multiple Dose in Adults with Nonobstructive Hypertrophic Cardiomyopathy | Experimental | EDG-7500 once daily for up to 28 days. |
|
| Part D: EDG-7500 Multiple Dose in Adults with Hypertrophic Cardiomyopathy | Experimental | EDG-7500 daily for up to 18 months in new participants and participants who have completed Part B or C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDG-7500 | Drug | Liquid suspension formulation of EDG-7500 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | From screening through study completion (Part A: Up to 38 days; Part B and C: Up to 73 days; Part D: Up to 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in left ventricular outflow tract (LVOT) gradient | Resting and post-Valsalva LVOT gradient by echocardiography | From baseline through study completion (Part A: Up to 10 days; Part B: Up to 38 days; Part D: Up to 18 months) |
| Pharmacokinetic parameters of EDG-7500 as measured by maximum plasma concentration (Cmax) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Edgewise Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Stanford University Hospital / Stanford Health Care |
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| EDG-7500 |
| Drug |
Solid oral formulation of EDG-7500 |
|
| From baseline through study completion (Part A: Up to 10 days) |
| Change from baseline in cardiac biomarkers | From baseline through study completion (Part B and C: Up to 38 days; Part D: Up to 18 months) |
| Stanford |
| California |
| 94305 |
| United States |
| Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Womens Hospital | Boston | Massachusetts | 02115 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Michigan Medicine - Michigan Clinical Research Unit | Ann Arbor | Michigan | 48109 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Morristown Medical Center (Atlantic Health System) | Morristown | New Jersey | 07960 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| NYU Langone Health Medical Center - HCM Program Office (Study open to existing NYU patients only) | New York | New York | 10016 | United States |
| Sanger Heart and Vascular Institute | Charlotte | North Carolina | 28204 | United States |
| Duke Health Center Arringdon | Morrisville | North Carolina | 27560 | United States |
| The Lindner Research Center at Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 33612 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University (OHSU) | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine) | Philadelphia | Pennsylvania | 19104 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Virginia Heart and Vascular Center Fontaine | Charlottesville | Virginia | 22903 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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