PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 14, 2019

Detailed Description

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

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 400 mg group
    • 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).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Otsuka Beijing Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tao Jiang, Master, Principal Investigator, Beijing Anding Hospital of Capital Medical University

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