| Primary | Pharmacokinetics: Cmax | Maximum plasma concentration of lumateperone | The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 and Day 5 | | | | ID | Title | Description |
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| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
| | | Title | Denominators | Categories |
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| Day 1 | | | | Day 5 | |
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| Primary | Pharmacokinetics: Tmax | Time of maximum concentration of lumateperone in plasma | The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC. | Posted | | Median | Full Range | h | | Day 1 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Primary | Pharmacokinetics: AUC0-t | Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone | The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC. | Posted | | Mean | Standard Deviation | h*ng/mL | | 0 to 24 hours post-dose on Day 1 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Primary | Pharmacokinetics: AUC0-tau | Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau) | The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC. | Posted | | Mean | Standard Deviation | h*ng/mL | | 0 to 24 hours post-dose on Day 1 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Primary | Pharmacokinetics: t1/2 | Terminal elimination half-life of lumateperone | The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC. | Posted | | Mean | Standard Deviation | h | | Day 1 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Primary | Pharmacokinetics: CL/F | Apparent oral clearance of lumateperone | The PK Analysis Population included all patients who received at least one dose of study drug, had no major protocol deviation that may have impacted PK analyses, and had measurable plasma concentrations to provide an estimate of at least Cmax or AUC. | Posted | | Mean | Standard Deviation | L/h | | Day 1 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Secondary | Percentage of Subjects With Treatment-emergent Adverse Events | | The Safety analysis population included all patients who took at least 1 dose of study drug. | Posted | | Count of Participants | | Participants | | up to 30 days after last dose, up to a total of 35 days | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Secondary | Change From Baseline in Systolic and Diastolic Blood Pressure | | The Safety analysis population included all patients who took at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Secondary | Change From Baseline in ECG QT Interval | | The Safety analysis population included all patients who took at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | msec | | Baseline and Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Secondary | Change From Baseline in Hemoglobin | | The Safety analysis population included all patients who took at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | g/dL | | Baseline and Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Secondary | Change From Baseline in White Blood Cell Count | | The Safety analysis population included all patients who took at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | cells*10^9/L | | Baseline and Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Secondary | Change From Baseline in Aspartate Aminotransferase | | The Safety analysis population included all patients who took at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | U/L | | Baseline and Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Secondary | Change From Baseline in Alanine Aminotransferase | | The Safety analysis population included all patients who took at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | U/L | | Baseline and Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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| Secondary | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) | AIMS is a measure of facial and oral movements, extremity movements and trunk movements. The AIMS total score is reported based on 7 items (items 1 through 7). Each item is rated on a scale from none (0) to severe (4). The AIMS total score ranges from 0 to 28. Higher values of total AIMS score indicate increased severity in abnormal movement. | The Safety analysis population included all patients who took at least 1 dose of study drug. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Lumateperone 42 mg Once Daily for 5 Days | Lumateperone 42 mg: Lumateperone 42 mg, oral administration |
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