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This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3-period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg, intact (whole) 200 mg and crushed 200 mg tablet via NG tube of cenobamate. All treatments will be administered under fasting conditions.
This study is a phase 1, randomized, open-label, single center, single-dose, 6-sequence, 3- period, 3-treatment crossover study in healthy adult male and female subjects to assess: the relative bioavailability of a crushed 200 mg cenobamate table in suspension administrated orally (Treatment B, Test 1) compared to an intact (whole) 200 mg cenobamate tablet administered orally (Treatment A, Reference), and the relative bioavailability of a crushed 200 mg cenobamate tablet in suspension administered via an NG tube (Treatment C, Test 2) versus an intact (whole) 200 mg cenobamate tablet (Treatment A, Reference). All treatments will be administered under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A (Reference) | Experimental | An intact 200 mg cenobamate tablet administered orally. |
|
| Treatment B (Test 1) | Experimental | A crushed 200 mg cenobamate tablet in suspension administrated orally. |
|
| Treatment C (Test 2) | Experimental | A crushed 200 mg cenobamate tablet in suspension administered via an NG tube |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenobamate | Drug | 200 mg Cenobamate Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration | up to 38 days |
| AUClast | AUC from the time 0 to the time of last measurable concentration | up to 38 days |
| AUCinf (AUC0-inf) | AUC from time 0 extrapolated to infinity | up to 38 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability - Adverse Events | Number of participants with adverse events (AEs) | up to 45 days |
| Safety and Tolerability - Clinical Laboratory Tests | Number of participants with clinical laboratory tests including clinical chemistry, hematology, coagulation, and urinalysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vijaykumar Vashi | SKLSI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
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| ID | Term |
|---|---|
| C000654784 | Cenobamate |
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Single-dose, 6-sequence, 3-period, 3-treatment crossover study
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| up to 45 days |
| Safety and Tolerability - Vitals Signs | Number of participants with vitals signs including systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature | up to 45 days |
| Safety and Tolerability - Physical Examination | Number of participants with physical examination | up to 45 days |
| Safety and Tolerability - ECG | Number of participants with ECG QT and RR Intervals | up to 45 days |
| Safety and Tolerability - Columbia Suicide Severity Rating Scale | Number of participants with Columbia Suicide Severity Rating Scale | up to 45 days |