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Part A of study was completed per protocol. Conduct of Part B of the study (confirmatory phase) was not necessary.
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| Name | Class |
|---|---|
| H. Lundbeck A/S | INDUSTRY |
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To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered subcutaneously or intramuscularly in adults with schizophrenia.
This trial is designed to assess the pharmacokinetics, safety and tolerability of brexpiprazole in the treatment of subjects with schizophrenia. The trial will consist of two parts across 13-36 months. The trial population will include approximately 110 male & female subjects between 18 and 64 years of age (inclusive) with a diagnosis of schizophrenia as defined by DSM-V criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Dose Injection: Subcutaneous | Experimental | Drug: Brexpiprazole, OPDC-34712 Once, subcutaneous |
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| Part A: Single Dose Injection: Intramuscular | Experimental | Drug: Brexpiprazole, OPDC-34712 Once, subcutaneous |
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| Part B: Cohort 1 | Experimental | Drug: Brexpiprazole, OPDC-34712 Once, SC or IM |
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| Part B: Cohort 2 | Experimental | Drug: Brexpiprazole, OPDC-34712 Once, SC or IM |
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| Part B: Cohort 3 | Experimental | Drug: Brexpiprazole, OPDC-34712 Once, SC or IM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brexpiprazole, OPDC-34712 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Suicidality via Columbia-Suicide Severity Rating Scale | Baseline version and Since Last Visit version of CSSRS will be completed by trained trial center staff | Part A: Screening to Day 182; Part B: Screening to Day 126 |
| Number of reported Adverse Events (AE) | Part A: 182 days; Part B: 126 days | |
| Clinical Laboratory Tests | Hematology, serum chemistry, urinalysis, drug screen, etc. will be performed. | Part A: 182 days; Part B: 126 days |
| Change in physical exam results | Investigator or designee will perform complete physical exam and document any clinically significant conditions. Body height and weight will also be measured for BMI calculation and weight will be measured as part of all subsequent physical exams. | Part A: Screening to Day 182; Part B: Screening to Day 126 |
| Change in Systolic/Diastolic blood pressure from screening to end of study | Heart rate and body temperature will also be obtained prior to PK blood draws and ECG. | Part A: Screening to Day 182; Part B: Screening to Day 126 |
| ECG Reading | 12-lead ECG will be collected in triplicate (5 minutes apart). heart rate, ventricular rate, RR interval, PR interval, QRS duration and QT intervals will be recorded. QTcF and corrected QT interval using Bazett's formula will be calculated. | Part A: 182 days; Part B: 126 days |
| Extrapyramidal Symptoms (EPS) Rating Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum peak plasma concentration (Cmax) [Pharmacokinetics] | Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded. PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuro Science (CNS) | Garden Grove | California | 92845 | United States | ||
| CNRI |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000591922 | brexpiprazole |
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SAS, AIMS & BARS will be assess by trained trial center staff |
| Part A: 182 days; Part B: 126 days |
| Investigator's assessment of injection site | Injection site will be assessed. Injection site will also be inspected for seepage after needle is withdrawn. | Part A: 182 days; Part B: 126 days |
| Visual analog scale (VAS) scores for pain reception | Part A: 182 days; Part B: 126 days |
| Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose) |
| Time of Cmax (tmax) [Pharmacokinetics] | Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded. PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411 | Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose) |
| Area under the concentration-time curve (AUC) from time zero to time "t" (Last observable concentration; AUCt) [Pharmacokinetics] | Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded. PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411 | Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose) |
| AUC from time zero to infinity (AUC∞) [Pharmacokinetics] | Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded. PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411 | Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose) |
| Terminal-phase elimination half-life (t1/2,z) [Pharmacokinetics] | Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded. PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411 | Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose) |
| Apparent clearance of drug from plasma after extravascular administration (CL/F; brexpiprazole only) [Pharmacokinetics] | Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded. PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411 | Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose) |
| San Diego |
| California |
| 92102 |
| United States |