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The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Healthy Japanese Adults | Experimental | Single and Multiple Dose EDG-7500 |
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| Cohort 2 - Healthy Japanese Adults | Experimental | Single and Multiple Dose EDG-7500 |
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| Cohort 3 - Healthy Caucasian Adults | Experimental | Single and Multiple Dose EDG-7500 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDG-7500 | Drug | Solid oral formulation of EDG-7500 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last | Area under the plasma concentration time-curve from time zero to the last measured concentration | Day 1 to Day 13 |
| AUC0-inf | Area under the plasma concentration time-curve from time zero extrapolated to infinity | Day 1 to Day 13 |
| AUCtau | Area under the concentration-time curve during the dosing interval | Day 1 to Day 13 |
| Cmax | Maximum plasma concentration observed | Day 1 to Day 13 |
| Cmax,ss | Maximum plasma concentration at steady state determined directly from the concentration-time profile | Day 1 to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - TEAEs | Incidence of treatment-emergent adverse events | Up to 23 days of monitoring |
| Tmax | Time to maximum plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edgewise Therapeutics, Inc. | Contact | 720-262-7002 | cardiacstudies@edgewisetx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel | Glendale | California | 91206 | United States |
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| Day 1 to Day 13 |
| AUC%extrap | Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast) | Day 1 to Day 13 |
| CL/F | Total body clearance | Day 1 to Day 13 |
| Vz/F | Apparent volume of distribution | Day 1 to Day 13 |
| T1/2 | Terminal elimination half-life | Day 1 to Day 13 |
| Ctrough,ss | Trough plasma concentration at steady state | Day 1 to Day 13 |
| Cavg,ss | Average plasma drug concentration during a dosing interval at steady state | Day 1 to Day 13 |
| RA(AUCtau) | Accumulation ratio for the area under the concentration-time curve during the dosing interval | Day 1 to Day 13 |
| RA(Cmax) | Accumulation ratio at the maximum concentration | Day 1 to Day 13 |