<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03285503</url>
  </required_header>
  <id_info>
    <org_study_id>031-403-00049</org_study_id>
    <nct_id>NCT03285503</nct_id>
  </id_info>
  <brief_title>PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Beijing Research Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Beijing Research Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM&#xD;
      Depot formulation at doses of 400mg in patients with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg&#xD;
      administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive&#xD;
      weeks&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2018</start_date>
  <completion_date type="Actual">October 14, 2019</completion_date>
  <primary_completion_date type="Actual">October 14, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>time of maximum observed plasma concentration (tmax)</measure>
    <time_frame>up to 24 week</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC672h</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent clearance after extravascular administration</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Examination</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Positive and Negative Symptoms Scale (PANSS)</measure>
    <time_frame>up to 24 weeks</time_frame>
    <description>To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>400 mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aripiprazole IM Depot</intervention_name>
    <description>administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.</description>
    <arm_group_label>400 mg group</arm_group_label>
    <other_name>ABILIFY MAINTENA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects, and their legal representatives(or their guardian ), who have signed the&#xD;
             informed consent form(ICF);&#xD;
&#xD;
          2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10,&#xD;
             295.20,295.90 , 295.60);&#xD;
&#xD;
          3. subjects, both male and female, who are at age between 18 and 64 (also including 18&#xD;
             and 64 years of age) at time of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of other mental disorders than schizophrenia confirmed through diagnostic&#xD;
             criteria of DSM-IV-TR;&#xD;
&#xD;
          2. Subjects who are alcoholomania or independent of drug, or have drug abuse history;&#xD;
&#xD;
          3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;&#xD;
&#xD;
        Other protocol-defined inclusion and exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tao Jiang, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anding Hospital of Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Anding Hospital of Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aripiprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03285503
org study id: 031-403-00049
nct id: NCT03285503
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Plasma Concentration (Cmax)
time frame: up to 24 weeks
description: To assess the Maximum Plasma Concentration (Cmax) of aripiprazole and its primary metabolite OPC-14857 after administration of the fifth IMD dose.
measure: time of maximum observed plasma concentration (tmax)
time frame: up to 24 week
description: 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.
measure: AUC672h
time frame: up to 24 weeks
description: 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.
measure: Apparent clearance after extravascular administration
time frame: up to 24 weeks
description: To assess the apparent clearance after extravascular administration (CL/F) of aripiprazole after administration of the fifth IMD dose.
measure: Adverse Events
time frame: up to 24 weeks
description: Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment
measure: Vital Signs
time frame: up to 24 weeks
description: Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
measure: Laboratory Examination
time frame: up to 24 weeks
description: Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin)
measure: Positive and Negative Symptoms Scale (PANSS)
time frame: up to 24 weeks
description: To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.
arm group label: 400 mg group
arm group type: Experimental
description: 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).
intervention type: Drug
intervention name: Aripiprazole IM Depot
description: administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.
arm group label: 400 mg group
other name: ABILIFY MAINTENA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Tao Jiang, Master
role: Principal Investigator
affiliation: Beijing Anding Hospital of Capital Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Aripiprazole
sharing ipd: Undecided