xml: <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/NCT06036108</url>
    </required_header>
    <id_info>
      <org_study_id>331-102-00151</org_study_id>
      <nct_id>NCT06036108</nct_id>
    </id_info>
    <brief_title>Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia</brief_title>
    <official_title>A Multicenter, Randomized, Open-label, 2-arm, 2-period Crossover Trial to Investigate the Effects of Food on the Pharmacokinetics of a Single Dose of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Otsuka Pharmaceutical Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole&#xD;
        QW formulation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum plasma concentration (Cmax) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state</measure>
      <time_frame>PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose</time_frame>
      <description>To evaluate Cmax of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under Curve (AUC) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state</measure>
      <time_frame>PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose</time_frame>
      <description>To evaluate AUC of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Schizophrenia</condition>
    <arm_group>
      <arm_group_label>Fasting-state administration group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Brexpiprazole QW formulation in a fasting-state administration</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Fed-state administration group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Brexpiprazole QW formulation in a fed-state administration</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>OPC-34712FUM/ Brexpiprazole fumarate</intervention_name>
      <description>In Period 1, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered at least 10 hours of fasting. In Period 2, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal.</description>
      <arm_group_label>Fasting-state administration group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>OPC-34712FUM/ Brexpiprazole fumarate</intervention_name>
      <description>In Period 1, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal. In Period 2, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered following at least 10 hours of fasting.</description>
      <arm_group_label>Fed-state administration group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informed&#xD;
               consent&#xD;
  &#xD;
            -  Patients who are able to be hospitalized for the protocol-defined hospitalization&#xD;
               period&#xD;
  &#xD;
            -  Patients with a body mass index [BMI = body weight (kg)/height (m)²] of 18.5 kg/m² or&#xD;
               higher and lower than 35.0 kg/m² at screening&#xD;
  &#xD;
            -  Patients who, in the judgment of the investigator, have stable psychotic symptoms&#xD;
               maintained by administration of an antipsychotic within the dosing range indicated&#xD;
               below, before commencement of IMP administration [Upper limit of dose and regimen]&#xD;
               Antipsychotic medication comprising no more than 2 active components, and a daily dose&#xD;
               equivalent to ≤600 mg/day of chlorpromazine&#xD;
  &#xD;
            -  Patients who are able to finish the high-fat meal specified in this protocol within 20&#xD;
               minutes&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a concurrent mental disorder besides schizophrenia who are judged by the&#xD;
               investigator to be unsuitable for participation in the trial&#xD;
  &#xD;
            -  Patients who have met the DSM-5® diagnostic criteria for substance-related or&#xD;
               addictive disorder, including alcohol and benzodiazepines but excluding caffeine and&#xD;
               tobacco, within 180 days before commencement of investigational medicinal product&#xD;
               (IMP) administration&#xD;
  &#xD;
            -  Patients who fall under any of the following criteria regarding suicidal ideation and&#xD;
               suicidal behavior&#xD;
  &#xD;
                 -  Patients who answered &quot;yes&quot; to Question 4 &quot;Active Suicidal Ideation with Some&#xD;
                    Intent to Act, without Specific Plan&quot; or Question 5 &quot;Active Suicidal Ideation&#xD;
                    with Specific Plan and Intent&quot; regarding C-SSRS suicidal ideation at screening&#xD;
                    (for the past 6 months) or at the Period 1 baseline examination (since the last&#xD;
                    assessment)&#xD;
  &#xD;
                 -  Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2&#xD;
                    years) or at the Period 1 baseline examination (since the last assessment)&#xD;
  &#xD;
                 -  Patients who present a serious risk of suicide based on the judgment of the&#xD;
                    investigator&#xD;
  &#xD;
            -  Patients who have previously undergone gastrointestinal surgery that could affect PK&#xD;
               evaluation&#xD;
  &#xD;
            -  Patients who have a clinically significant neurological, hepatic, renal, metabolic,&#xD;
               hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder.&#xD;
               Medical conditions that are minor or well-controlled may be considered acceptable if&#xD;
               the condition does not interfere with safety and PK assessments.&#xD;
  &#xD;
            -  Patients who are using clozapine at the time of informed consent&#xD;
  &#xD;
            -  Patients whose clinical symptoms have worsened to the point where use of prohibited&#xD;
               concomitant therapy or medication is required during the washout period for prior&#xD;
               medication&#xD;
  &#xD;
            -  Patients whose cytochrome P450 2D6 (CYP2D6) phenotype is judged to be either poor&#xD;
               metabolizers (PM) or Unknown based on the results of CYP2D6 genotyping at screening&#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>Takehisa Matsumaru</last_name>
      <role>Study Director</role>
      <affiliation>Otsuka Pharmaceutical Co., Ltd.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Drug Information Center</last_name>
      <phone>+81-3-6361-7314</phone>
    </overall_contact>
    <location>
      <facility>
        <name>Rainbow &amp; Sea Hospital</name>
        <address>
          <city>Saga-shi</city>
          <country>Japan</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>Brexpiprazole</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.</ipd_time_frame>
      <ipd_access_criteria>Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036108
  org study id: 331-102-00151
  nct id: NCT06036108
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole
        QW formulation.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Maximum plasma concentration (Cmax) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state
  time frame: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose
  description: To evaluate Cmax of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state
  measure: Area Under Curve (AUC) of brexpiprazole in plasma after administration in a fed state versus administration in a fasting state
  time frame: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose
  description: To evaluate AUC of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state
  arm group label: Fasting-state administration group
  arm group type: Experimental
  description: Brexpiprazole QW formulation in a fasting-state administration
  arm group label: Fed-state administration group
  arm group type: Experimental
  description: Brexpiprazole QW formulation in a fed-state administration
  intervention type: Drug
  intervention name: OPC-34712FUM/ Brexpiprazole fumarate
  description: In Period 1, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered at least 10 hours of fasting. In Period 2, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal.
  arm group label: Fasting-state administration group
  intervention type: Drug
  intervention name: OPC-34712FUM/ Brexpiprazole fumarate
  description: In Period 1, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal. In Period 2, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered following at least 10 hours of fasting.
  arm group label: Fed-state administration group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Takehisa Matsumaru
  role: Study Director
  affiliation: Otsuka Pharmaceutical Co., Ltd.
  last name: Drug Information Center
  phone: +81-3-6361-7314
  facility: 
  status: Recruiting
  country: Japan
  responsible party type: Sponsor
  mesh term: Schizophrenia
  mesh term: Brexpiprazole
  sharing ipd: Yes
  ipd description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
  ipd access criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.