PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Study Overview
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Brief Summary
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This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.

Detailed Description
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To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks

Official Title
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A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Aripiprazole IM Depot


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF); Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60); subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent. Exclusion Criteria: Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR; Subjects who are alcoholomania or independent of drug, or have drug abuse history; Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing; Other protocol-defined inclusion and exclusion criteria may apply.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 400 mg group<br>Aripiprazole IM depot 400mg will be administered every four weeks for 20 weeks after drug switch / steady dose of oral aripiprazole tablets (each subject will receive 5 intramuscular injections totally). | Drug: Aripiprazole IM Depot<br>* administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.<br>* Other names: ABILIFY MAINTENA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) | To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose. | up to 24 weeks | 
| time of maximum observed plasma concentration (tmax) | To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose. | up to 24 week | 
| AUC672h | To assess the time of maximum observed plasma concentration (tmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose. | up to 24 weeks | 
| Apparent clearance after extravascular administration | To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose. | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment | up to 24 weeks | 
| Vital Signs | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs | up to 24 weeks | 
| Laboratory Examination | Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin) | up to 24 weeks |