PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Otsuka Beijing Research Institute12 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

Aripiprazole IM DepotDRUG

administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF); 2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60); 3. 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: 1. Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR; 2. Subjects who are alcoholomania or independent of drug, or have drug abuse history; 3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing; Other protocol-defined inclusion and exclusion criteria may apply.

Locations (1)

Beijing Anding Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: up to 24 weeks

Secondary Outcomes

Adverse Events

Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment

Time frame: 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

Time frame: 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)

Data from ClinicalTrials.gov

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