A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to determine the pharmacokinetics (PK), tolerability and safety of brexpiprazole LAI following a single administration in subjects with schizophrenia.

Official Title
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A Multicenter, Open-label, Clinical Pharmacology Trial to Determine the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Brexpiprazole LAI: Dose 1
* Drug: Brexpiprazole LAI: Dose 2
* Drug: Brexpiprazole LAI: Dose 3
* Drug: Brexpiprazole LAI: Dose 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Japanese patients who are between 18 and 64 years of age, inclusive, at the time of informed consent Patients with a diagnosis of schizophrenia as defined by the DSM-5® criteria Patients who are able to remain at the trial site for the protocol-defined hospitalization period Patients with a body mass index [BMI = body weight (kg) / height (m)2] of no less than 18.5 kg/m2 and less than 35.0 kg/m2 at screening Patients who are able to provide written informed consent (if the patient is a minor or is hospitalized for medical protection, his or her legally acceptable representative must also give informed consent) prior to commencement of any trial procedure and are judged by the investigator or subinvestigator to be able to meet all protocol-defined requirements Exclusion Criteria: Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (eg, schizoaffective disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder) as defined by the DSM-5® criteria. However, this exclusion does not apply to caffeine- or tobacco-related disorders. Patients who fail to meet the mandatory washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of the drugs or foods during the trial period Patients who have received electroconvulsive therapy (ECT) within 60 days prior to the administration of IMP Patients with clinically significant nervous, hepatic, renal, metabolic, blood, immune, cardiovascular, respiratory, or digestive system disorders However, such patients may be enrolled if the condition is mild or well controlled and is considered to not affect safety or PK evaluations. Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days prior to the administration of IMP Patients with a positive drug test at screening (according to the results from the central laboratory). However, such patients may be enrolled if their condition is not diagnosed as a substance-related or addictive disorder, according to the DSM-5® diagnostic criteria.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brexpiprazole LAI: Dose 1<br> | Drug: Brexpiprazole LAI: Dose 1<br>* Cohort 1: Single Dose Intramuscular Injection: Brexpiprazole LAI Dose 1<br>|
| Experimental: Brexpiprazole LAI: Dose 2<br> | Drug: Brexpiprazole LAI: Dose 2<br>* Cohort 2: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 2<br>|
| Experimental: Brexpiprazole LAI: Dose 3<br> | Drug: Brexpiprazole LAI: Dose 3<br>* Cohort 3: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 3<br>|
| Experimental: Brexpiprazole LAI: Dose 4<br> | Drug: Brexpiprazole LAI: Dose 4<br>* Cohort 4: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of brexpiprazole |  | Blood Sampling for plasma drug measurement Day 1 (predose and 4, 8, 12 hours postdose), 2, 3, 5,7,9,11,13,15,17,19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 112, 126, 154, 182 |