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The purposes of this Phase 1 study of sevasemten are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: single dose sevasemten | Experimental | Single dose sevasemten administered on Day 1 under fasting conditions |
|
| Treatment B: multiple doses of verapamil and single dose of sevasemten | Experimental | Multiple doses of verapamil with a single dose of sevasemten under fasting conditions |
|
| Treatment C: single dose sevasemten and high-fat meal | Experimental | Single dose sevasemten under high-fat fed conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sevasemten | Drug | single dose 10mg sevasemten administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic | The area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) for sevasemten and metabolites administered with and without verapamil | Up to 46 days of monitoring |
| Pharmacokinetic | The maximum observed concentration (Cmax) for sevasemten and metabolites administered with and without verapamil | Up to 46 days of monitoring |
| Pharmacokinetic | The area under the concentration-time curve, from time 0 to the last observed non-zero concentration (AUC0-t) for sevasemten and metabolites under fasting and fed conditions | up to 42 days of monitoring |
| Pharmacokinetic | The maximum observed concentration (Cmax) for sevasemten and metabolites under fasting and fed conditions | up to 42 days of monitoring |
| Pharmacokinetic | The time to reach the maximum observed concentration (Tmax) for sevasemten and metabolites under fasting and fed conditions | up to 42 days of monitoring |
| Pharmacokinetic | The lag time, time delayed between drug administration and the onset of absorption (Tlag), for sevasemten and metabolites under fasting and fed conditions | up to 42 days of monitoring |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence of treatment emergent adverse events in those with a single dose of sevasemten administered with and without verapamil and with or without food | Up to 46 days of monitoring |
| Safety and Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roxana D Dreghici, MD | Edgewise Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States | ||
| Celerion |
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| ID | Term |
|---|---|
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Verapamil | Drug | multiple doses 240mg verapamil |
|
Incidence of abnormal chemistry test results in those with a single dose of sevasemten administered with and without verapamil and with or without food
| Up to 46 days of monitoring |
| Safety and Tolerability | Incidence of abnormal hematology test results in those with a single dose of sevasemten administered with and without verapamil and with or without food | Up to 46 days of monitoring |
| Safety and Tolerability | Incidence of abnormal urinalysis test results in those with a single dose of sevasemten administered with and without verapamil and with or without food | Up to 46 days of monitoring |
| Safety and Tolerability | Incidence of abnormal heart rate results in those with a single dose of sevasemten administered with and without verapamil and with or without food | Up to 46 days of monitoring |
| Safety and Tolerability | Incidence of abnormal blood pressure results in those with a single dose of sevasemten administered with and without verapamil and with or without food | Up to 46 days of monitoring |
| Safety and Tolerability | Incidence of abnormal body temperature results in those with a single dose of sevasemten administered with and without verapamil and with or without food | Up to 46 days of monitoring |
| Safety and Tolerability | Incidence of abnormal respiratory rate results in those with a single dose of sevasemten administered with and without verapamil and with or without food | Up to 46 days of monitoring |
| Safety and Tolerability | Incidence of abnormal 12-lead ECG results in those with a single dose of sevasemten administered with and without verapamil and with or without food | Up to 46 days of monitoring |
| Lincoln |
| Nebraska |
| 68502 |
| United States |