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The purposes of this Phase 1 study of EDG-15400 are to:
Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose | Experimental | Single oral ascending dose in fasted healthy adults |
|
| Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses | Experimental | Multiple oral ascending doses once daily in fasted healthy adults |
|
| Part C: Healthy Adult (Ages ≥18 to <60 years) Food Effect and Relative Bioavailability | Experimental | Crossover food effect (fed versus fasted) single oral dose in healthy adults and relative bioavailability of liquid versus solid formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDG-15400 | Drug | EDG-15400 is administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of treatment-emergent adverse events | To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults | Up to 25 days of monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of Tmax | Time to maximum concentration (Tmax) | Up to 25 days |
| Determination of Cmax | Maximum observed concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
Additional protocol defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Contact: Edgewise Therapeutics, Inc. | Contact | 720-262-7002 | cardiacstudies@edgewisetx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Recruiting | Tempe | Arizona | 85283 | United States |
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| Placebo | Drug | Placebo is administered orally |
|
| Up to 25 days |
| Determination of AUC | Area under the concentration-time curve (AUC) | Up to 25 days |
| Determination of t1/2 | Elimination half-life (t1/2) | Up to 25 days |
| Determination of V/F | Apparent volume of distribution after oral administration (V/F) | Up to 25 days |
| Determination of CL/F | Apparent clearance of drug after oral administration (CL/F) | Up to 25 days |
| Determination of CLr | Renal clearance (CLr) | Up to 25 days |