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The purposes of this Phase 1 study of EDG-7500 are to:
Participants will receive a single or multiple doses of EDG-7500 or a placebo by mouth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose | Experimental | Single oral ascending dose in healthy volunteers ages ≥ 18 to < 60 years |
|
| Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses | Experimental | Multiple oral ascending doses in healthy volunteers ages ≥ 18 to < 60 years |
|
| Part D: Healthy Volunteer Food Effect and Relative Bioavailability | Experimental | Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDG-7500 | Drug | EDG-7500 is administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: incidence of treatment-emergent adverse events | To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses | Up to 25 days of monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of pharmacokinetics parameters as measured by Tmax | Time to maximum concentration (Tmax) | Up to 25 days of monitoring |
| Determination of pharmacokinetic parameters as measured by Cmax |
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Inclusion Criteria:
Exclusion Criteria:
Additional protocol defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Edgewise Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States | ||
| Celerion |
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| Placebo | Drug | Placebo is administered orally once daily |
|
Maximum observed concentration (Cmax)
| Up to 25 days of monitoring |
| Determination of pharmacokinetic parameters as measured by AUC | Area under the concentration-time curve (AUC) | Up to 25 days of monitoring |
| Determination of pharmacokinetic parameters as measured by t1/2 | Terminal half-life (t1/2) | Up to 25 days of monitoring |
| Determination of renal clearance as measured by CLr | Renal clearance (CLr) | Up to 25 days of monitoring |
| Lincoln |
| Nebraska |
| 68502 |
| United States |