<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/NCT02968121</url>
  </required_header>
  <id_info>
    <org_study_id>331-201-00033</org_study_id>
    <nct_id>NCT02968121</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability Study of Single-dose Administration of Brexpiprazole in Adult Subjects With Schizophrenia</brief_title>
  <official_title>A Phase 1, Two-part, Open-label, Randomized, Exploratory and Single Ascending Dose, Parallel Arm Trial to Determine the Pharmacokinetics, Safety, and Tolerability of Brexpiprazole Long-acting Injectable Administered Subcutaneously or Intramuscularly in Adult Subjects With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered&#xD;
      subcutaneously or intramuscularly in adults with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is designed to assess the pharmacokinetics, safety and tolerability of&#xD;
      brexpiprazole in the treatment of subjects with schizophrenia. The trial will consist of two&#xD;
      parts across 13-36 months. The trial population will include approximately 110 male &amp; female&#xD;
      subjects between 18 and 64 years of age (inclusive) with a diagnosis of schizophrenia as&#xD;
      defined by DSM-V criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Part A of study was completed per protocol. Conduct of Part B of the study (confirmatory phase)&#xD;
    was not necessary.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 14, 2017</completion_date>
  <primary_completion_date type="Actual">December 14, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Suicidality via Columbia-Suicide Severity Rating Scale</measure>
    <time_frame>Part A: Screening to Day 182; Part B: Screening to Day 126</time_frame>
    <description>Baseline version and Since Last Visit version of CSSRS will be completed by trained trial center staff</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of reported Adverse Events (AE)</measure>
    <time_frame>Part A: 182 days; Part B: 126 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Laboratory Tests</measure>
    <time_frame>Part A: 182 days; Part B: 126 days</time_frame>
    <description>Hematology, serum chemistry, urinalysis, drug screen, etc. will be performed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in physical exam results</measure>
    <time_frame>Part A: Screening to Day 182; Part B: Screening to Day 126</time_frame>
    <description>Investigator or designee will perform complete physical exam and document any clinically significant conditions. Body height and weight will also be measured for BMI calculation and weight will be measured as part of all subsequent physical exams.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Systolic/Diastolic blood pressure from screening to end of study</measure>
    <time_frame>Part A: Screening to Day 182; Part B: Screening to Day 126</time_frame>
    <description>Heart rate and body temperature will also be obtained prior to PK blood draws and ECG.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ECG Reading</measure>
    <time_frame>Part A: 182 days; Part B: 126 days</time_frame>
    <description>12-lead ECG will be collected in triplicate (5 minutes apart). heart rate, ventricular rate, RR interval, PR interval, QRS duration and QT intervals will be recorded. QTcF and corrected QT interval using Bazett's formula will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extrapyramidal Symptoms (EPS) Rating Scale</measure>
    <time_frame>Part A: 182 days; Part B: 126 days</time_frame>
    <description>SAS, AIMS &amp; BARS will be assess by trained trial center staff</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Investigator's assessment of injection site</measure>
    <time_frame>Part A: 182 days; Part B: 126 days</time_frame>
    <description>Injection site will be assessed. Injection site will also be inspected for seepage after needle is withdrawn.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual analog scale (VAS) scores for pain reception</measure>
    <time_frame>Part A: 182 days; Part B: 126 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum peak plasma concentration (Cmax) [Pharmacokinetics]</measure>
    <time_frame>Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)</time_frame>
    <description>Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.&#xD;
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Cmax (tmax) [Pharmacokinetics]</measure>
    <time_frame>Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)</time_frame>
    <description>Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.&#xD;
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration-time curve (AUC) from time zero to time &quot;t&quot; (Last observable concentration; AUCt) [Pharmacokinetics]</measure>
    <time_frame>Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)</time_frame>
    <description>Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.&#xD;
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC from time zero to infinity (AUC∞) [Pharmacokinetics]</measure>
    <time_frame>Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)</time_frame>
    <description>Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.&#xD;
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal-phase elimination half-life (t1/2,z) [Pharmacokinetics]</measure>
    <time_frame>Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)</time_frame>
    <description>Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.&#xD;
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent clearance of drug from plasma after extravascular administration (CL/F; brexpiprazole only) [Pharmacokinetics]</measure>
    <time_frame>Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)</time_frame>
    <description>Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.&#xD;
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Part A: Single Dose Injection: Subcutaneous</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Brexpiprazole, OPDC-34712 Once, subcutaneous</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: Single Dose Injection: Intramuscular</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Brexpiprazole, OPDC-34712 Once, subcutaneous</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Brexpiprazole, OPDC-34712 Once, SC or IM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Brexpiprazole, OPDC-34712 Once, SC or IM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Brexpiprazole, OPDC-34712 Once, SC or IM</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brexpiprazole, OPDC-34712</intervention_name>
    <arm_group_label>Part A: Single Dose Injection: Intramuscular</arm_group_label>
    <arm_group_label>Part A: Single Dose Injection: Subcutaneous</arm_group_label>
    <arm_group_label>Part B: Cohort 1</arm_group_label>
    <arm_group_label>Part B: Cohort 2</arm_group_label>
    <arm_group_label>Part B: Cohort 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females between 18 and 64 years of age, inclusive, at the screening visit&#xD;
             with a diagnosis of schizophrenia as defined by DSM-V criteria.&#xD;
&#xD;
          -  Body mass index between 18 and 35 kg/m^2 at the screening visit.&#xD;
&#xD;
          -  Good physical health as determined by no clinically significant deviation from normal.&#xD;
&#xD;
          -  Ability to provide informed consent and/or consent obtained from a legally acceptable&#xD;
             representative (as required by IRB), prior to the initiation of any protocol-required&#xD;
             procedures.&#xD;
&#xD;
          -  Male and female subjects who are surgically sterile, female subjects who have been&#xD;
             postmenopausal for at least 12 consecutive months prior to the screening visit, or&#xD;
             male subjects/female subjects (of childbearing potential) who agree to remain&#xD;
             abstinent or to practice 2 of the approved birth control methods from the screening&#xD;
             visit and for at least 150 days after the dose of IMP for a female subject or 180 days&#xD;
             after the dose of IMP for a male subject.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have:&#xD;
&#xD;
          -  Met DSM-V criteria for substance use disorder within the past 180 days; including&#xD;
             alcohol and benzodiazepines, excluding caffeine/nicotine.&#xD;
&#xD;
          -  A positive drug screen for drugs of abuse (excluding stimulants, other prescribed&#xD;
             medications, and marijuana [if in investigator's documented opinion the subject does&#xD;
             not meet DSM-V criteria for substance use disorder]).&#xD;
&#xD;
          -  Use of more than 1 psychotropic medication at the screening or baseline visit, except&#xD;
             for oral brexpiprazole administered during the brexpiprazole tolerability testing (if&#xD;
             applicable) and current oral antipsychotic medication.&#xD;
&#xD;
          -  Use of varenicline beyond screening.&#xD;
&#xD;
          -  Subjects who have participated in any clinical trial involving a psychotropic&#xD;
             medication within 1 month prior to the administration of IMP or 5 half-lives from last&#xD;
             IMP administration whichever is longer.&#xD;
&#xD;
          -  Subjects who have a significant risk of committing suicide based on history, routine&#xD;
             psychiatric status examination, investigator's judgment, or who have an answer of&#xD;
             &quot;yes&quot; on questions 4 or 5 on the Baseline Version of the C-SSRS.&#xD;
&#xD;
          -  Subjects currently in an acute relapse of schizophrenia as assessed by the&#xD;
             investigator.&#xD;
&#xD;
          -  Subjects with a current DSM-V diagnosis other than schizophrenia. Also, subjects with&#xD;
             borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality&#xD;
             disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Collaborative Neuro Science (CNS)</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CNRI</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>January 10, 2018</last_update_submitted>
  <last_update_submitted_qc>January 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</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>
  <!-- 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/NCT02968121
org study id: 331-201-00033
nct id: NCT02968121
lead sponsor: 
collaborator: 
has dmc: No
To determine the pharmacokinetics, safety and tolerability of brexpiprazole administered
      subcutaneously or intramuscularly in adults with schizophrenia.
This trial is designed to assess the pharmacokinetics, safety and tolerability of
      brexpiprazole in the treatment of subjects with schizophrenia. The trial will consist of two
      parts across 13-36 months. The trial population will include approximately 110 male & female
      subjects between 18 and 64 years of age (inclusive) with a diagnosis of schizophrenia as
      defined by DSM-V criteria.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in Suicidality via Columbia-Suicide Severity Rating Scale
time frame: Part A: Screening to Day 182; Part B: Screening to Day 126
description: Baseline version and Since Last Visit version of CSSRS will be completed by trained trial center staff
measure: Number of reported Adverse Events (AE)
time frame: Part A: 182 days; Part B: 126 days
measure: Clinical Laboratory Tests
time frame: Part A: 182 days; Part B: 126 days
description: Hematology, serum chemistry, urinalysis, drug screen, etc. will be performed.
measure: Change in physical exam results
time frame: Part A: Screening to Day 182; Part B: Screening to Day 126
description: Investigator or designee will perform complete physical exam and document any clinically significant conditions. Body height and weight will also be measured for BMI calculation and weight will be measured as part of all subsequent physical exams.
measure: Change in Systolic/Diastolic blood pressure from screening to end of study
time frame: Part A: Screening to Day 182; Part B: Screening to Day 126
description: Heart rate and body temperature will also be obtained prior to PK blood draws and ECG.
measure: ECG Reading
time frame: Part A: 182 days; Part B: 126 days
description: 12-lead ECG will be collected in triplicate (5 minutes apart). heart rate, ventricular rate, RR interval, PR interval, QRS duration and QT intervals will be recorded. QTcF and corrected QT interval using Bazett's formula will be calculated.
measure: Extrapyramidal Symptoms (EPS) Rating Scale
time frame: Part A: 182 days; Part B: 126 days
description: SAS, AIMS & BARS will be assess by trained trial center staff
measure: Investigator's assessment of injection site
time frame: Part A: 182 days; Part B: 126 days
description: Injection site will be assessed. Injection site will also be inspected for seepage after needle is withdrawn.
measure: Visual analog scale (VAS) scores for pain reception
time frame: Part A: 182 days; Part B: 126 days
measure: Maximum peak plasma concentration (Cmax) [Pharmacokinetics]
time frame: Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)
description: Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411.
measure: Time of Cmax (tmax) [Pharmacokinetics]
time frame: Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)
description: Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411
measure: Area under the concentration-time curve (AUC) from time zero to time "t" (Last observable concentration; AUCt) [Pharmacokinetics]
time frame: Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)
description: Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411
measure: AUC from time zero to infinity (AUC∞) [Pharmacokinetics]
time frame: Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)
description: Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411
measure: Terminal-phase elimination half-life (t1/2,z) [Pharmacokinetics]
time frame: Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)
description: Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411
measure: Apparent clearance of drug from plasma after extravascular administration (CL/F; brexpiprazole only) [Pharmacokinetics]
time frame: Day 1 (predose [within 2 hours prior to dosing] and 4, 8 , and 12 hours postdose)
description: Samples will also be collected on Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112, 126, 154, and 182/ET or until plasma concentrations of brexpiprazole are BLQ, whichever is longer based on monthly PK sampling (samples will be collected between 8 AM and 2 PM on the indicated nondosing day). If a PK blood sample cannot be drawn at the designated time on Day 1, a window of ± 15 minutes for each blood draw is acceptable with the exact time recorded.
PK parameters will be assessed for plasma brexpiprazole and its metabolite(s) including DM-3411
arm group label: Part A: Single Dose Injection: Subcutaneous
arm group type: Experimental
description: Drug: Brexpiprazole, OPDC-34712 Once, subcutaneous
arm group label: Part A: Single Dose Injection: Intramuscular
arm group type: Experimental
description: Drug: Brexpiprazole, OPDC-34712 Once, subcutaneous
arm group label: Part B: Cohort 1
arm group type: Experimental
description: Drug: Brexpiprazole, OPDC-34712 Once, SC or IM
arm group label: Part B: Cohort 2
arm group type: Experimental
description: Drug: Brexpiprazole, OPDC-34712 Once, SC or IM
arm group label: Part B: Cohort 3
arm group type: Experimental
description: Drug: Brexpiprazole, OPDC-34712 Once, SC or IM
intervention type: Drug
intervention name: Brexpiprazole, OPDC-34712
arm group label: Part A: Single Dose Injection: Intramuscular
arm group label: Part A: Single Dose Injection: Subcutaneous
arm group label: Part B: Cohort 1
arm group label: Part B: Cohort 2
arm group label: Part B: Cohort 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Brexpiprazole