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/NCT05965219</url>
    </required_header>
    <id_info>
      <org_study_id>CVL-231-HV-1010</org_study_id>
      <nct_id>NCT05965219</nct_id>
    </id_info>
    <brief_title>A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants</brief_title>
    <official_title>A Phase 1, Open-label, Three-Part, Fixed-Sequence Trial in Healthy Adult Participants to Evaluate the Effects of Itraconazole and Carbamazepine on the Single-Dose Pharmacokinetics of Emraclidine, and the Effect of Emraclidine on the Single-Dose Pharmacokinetics of Metformin</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cerevel Therapeutics, LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cerevel Therapeutics, LLC</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of the study is to evaluate the effect of itraconazole, a strong&#xD;
        cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and&#xD;
        metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the&#xD;
        PK of emraclidine and metabolite CV-0000364 in Part B, and to evaluate the effect of&#xD;
        emraclidine on the PK of metformin in Part C in healthy adult participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 15, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part B: Cmax of Emraclidine and its Metabolite CV-0000364</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part C: Cmax of Metformin</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part B: AUC0-t of Emraclidine and its Metabolite CV-0000364</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part C: AUC0-t of Metformin</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part B: AUCinf of Emraclidine and its Metabolite CV-0000364</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part C: AUCinf of Metformin</measure>
      <time_frame>Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs) Based on Severity</measure>
      <time_frame>From the first dose up to 1 month following last dose with investigational medicinal product (IMP) in each part of the study</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values</measure>
      <time_frame>Up to end of treatment in each part of the study (up to an average of 15 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant Changes in Vital Sign Measurements</measure>
      <time_frame>Up to end of treatment in each part of the study (up to an average of 15 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant Changes in Laboratory Assessments</measure>
      <time_frame>Up to end of treatment in each part of the study (up to an average of 15 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results</measure>
      <time_frame>Up to end of treatment in each part of the study (up to an average of 15 days)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score</measure>
      <time_frame>Up to end of treatment in each part of the study (up to an average of 15 days)</time_frame>
      <description>The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Part A: Emraclidine Followed by Itraconazole + Emraclidine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B: Emraclidine Followed by Carbamazepine + Emraclidine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part C: Metformin Followed by Emraclidine + Metformin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Emraclidine</intervention_name>
      <description>Emraclidine tablets.</description>
      <arm_group_label>Part A: Emraclidine Followed by Itraconazole + Emraclidine</arm_group_label>
      <arm_group_label>Part B: Emraclidine Followed by Carbamazepine + Emraclidine</arm_group_label>
      <arm_group_label>Part C: Metformin Followed by Emraclidine + Metformin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Itraconazole</intervention_name>
      <description>Itraconazole oral solution.</description>
      <arm_group_label>Part A: Emraclidine Followed by Itraconazole + Emraclidine</arm_group_label>
      <other_name>Sporanox</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carbamazepine</intervention_name>
      <description>Carbamazepine tablets.</description>
      <arm_group_label>Part B: Emraclidine Followed by Carbamazepine + Emraclidine</arm_group_label>
      <other_name>Tegretol-XR</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Metformin</intervention_name>
      <description>Metformin tablets.</description>
      <arm_group_label>Part C: Metformin Followed by Emraclidine + Metformin</arm_group_label>
      <other_name>Glucophage</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria for All Participants:&#xD;
  &#xD;
            -  Healthy as determined by medical evaluation, including medical and psychiatric&#xD;
               history, physical and neurological examinations, ECG, vital sign measurements, and&#xD;
               laboratory test results, as evaluated by the investigator.&#xD;
  &#xD;
            -  Body mass index of 18.5 to 35.0 kilograms per square meter (kg/m^2), inclusive, and a&#xD;
               total body weight ≥50 kilograms (kg) (110 pounds [lbs]).&#xD;
  &#xD;
          Inclusion Criteria for Part A:&#xD;
  &#xD;
            -  Male and female (women of nonchildbearing potential only) participants, ages 18 to 55&#xD;
               years, inclusive, at the time of signing the informed consent form (ICF).&#xD;
  &#xD;
          Inclusion Criteria for Part B:&#xD;
  &#xD;
            -  Male and female (women of nonchildbearing potential only) participants, ages 18 to 55&#xD;
               years, inclusive, at the time of signing the ICF.&#xD;
  &#xD;
          Inclusion Criteria for Part C:&#xD;
  &#xD;
            -  Male and female (both women of childbearing and nonchildbearing potential)&#xD;
               participants, ages 18 to 55 years, inclusive, at the time of signing the ICF.&#xD;
  &#xD;
            -  Sexually active women of childbearing potential must agree to use at least an&#xD;
               acceptable birth control method during the trial and for 7 days after the last dose of&#xD;
               IMP. Acceptable birth control methods that result in a failure rate of more than 1%&#xD;
               per year include the following:&#xD;
  &#xD;
                 -  Progestogen-only oral hormonal contraception, where inhibition of ovulation is&#xD;
                    not the primary mode of action&#xD;
  &#xD;
                 -  Male or female condom with or without spermicide&#xD;
  &#xD;
                 -  Cap, diaphragm, or sponge with spermicide&#xD;
  &#xD;
          Exclusion Criteria for All Participants:&#xD;
  &#xD;
            -  Current or past history of significant cardiovascular, pulmonary, gastrointestinal,&#xD;
               renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus,&#xD;
               thyroid disorders), malignancy, hematological, immunological, neurological, or&#xD;
               psychiatric disease that, in the opinion of the investigator or medical monitor, could&#xD;
               compromise either participant safety or the results of the trial.&#xD;
  &#xD;
            -  &quot;Yes&quot; responses for any of the following items on the C-SSRS (within the individual's&#xD;
               lifetime):&#xD;
  &#xD;
                 -  Suicidal Ideation Item 3 (Active Suicidal Ideation With Any Methods [Not Plan]&#xD;
                    Without Intent to Act)&#xD;
  &#xD;
                 -  Suicidal Ideation Item 4 (Active Suicidal Ideation With Some Intent to Act,&#xD;
                    Without Specific Plan)&#xD;
  &#xD;
                 -  Suicidal Ideation Item 5 (Active Suicidal Ideation With Specific Plan and Intent)&#xD;
  &#xD;
                 -  Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted&#xD;
                    Attempt, or Preparatory Acts/Behavior)&#xD;
  &#xD;
            -  &quot;Yes&quot; responses for any of the following items on the C-SSRS (within past 12 months):&#xD;
  &#xD;
                 -  Suicidal Ideation Item 1 (Wish to be Dead)&#xD;
  &#xD;
                 -  Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts)&#xD;
  &#xD;
            -  Serious risk of suicide in the opinion of the investigator is also exclusionary.&#xD;
  &#xD;
            -  Any condition or surgery that could possibly affect drug absorption, including, but&#xD;
               not limited to, bowel resections, bariatric weight loss surgery/procedures,&#xD;
               gastrectomy, and cholecystectomy.&#xD;
  &#xD;
            -  Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface&#xD;
               antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable&#xD;
               viral ribonucleic acid (RNA) levels at Screening.&#xD;
  &#xD;
            -  Positive drug screen (including cotinine and tetrahydrocannabinol [THC]) or a positive&#xD;
               test for alcohol.&#xD;
  &#xD;
          Exclusion Criteria for Part A:&#xD;
  &#xD;
            -  History of presence of any of the following and deemed clinically significant by the&#xD;
               investigator or designee and confirmed by the medical monitor:&#xD;
  &#xD;
                 -  Ventricular dysfunction or risk factors for torsades de pointes (e.g., heart&#xD;
                    failure, cardiomyopathy, family history of long-QT syndrome)&#xD;
  &#xD;
            -  Any of the following clinical laboratory test results at the Screening Visit or&#xD;
               Check-in (Day -1), which can be confirmed by a single repeat measurement, if deemed&#xD;
               necessary:&#xD;
  &#xD;
                 -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) &gt; upper limit&#xD;
                    of normal (ULN).&#xD;
  &#xD;
                 -  Total bilirubin &gt;ULN. If Gilbert's syndrome is suspected, total bilirubin &gt;ULN is&#xD;
                    acceptable if the conjugated or direct bilirubin fraction is &lt;20% of total&#xD;
                    bilirubin.&#xD;
  &#xD;
                 -  Hypokalemia (potassium levels &lt; lower limit of normal [LLN] millimoles per liter&#xD;
                    [mmol/L]), and/or hypomagnesemia (magnesium levels &lt;1.2 milligrams per deciliter&#xD;
                    [mg/dL]; &lt;0.5 mmol/L), and/or hypocalcemia (corrected serum calcium &lt;8.0 mg/dL or&#xD;
                    ionized calcium &lt;1.0 mmol/L).&#xD;
  &#xD;
          Exclusion Criteria for Part B:&#xD;
  &#xD;
            -  Participants positive for human leukocyte antigen (HLA)-B*1502 or HLA-A*3101.&#xD;
  &#xD;
            -  Family history of drug reaction with eosinophilia and systemic symptoms (DRESS).&#xD;
  &#xD;
            -  Family history of porphyria.&#xD;
  &#xD;
            -  History of cardiac conduction disturbance including second- and third-degree&#xD;
               atrioventricular heart block.&#xD;
  &#xD;
            -  Any of the following clinical laboratory test results at the Screening Visit or&#xD;
               Check-in (Day -1), which can be confirmed by a single repeat measurement:&#xD;
  &#xD;
                 -  Platelets, white blood cell count, absolute neutrophil count, or hemoglobin &lt;LLN.&#xD;
  &#xD;
                 -  Serum sodium &lt;LLN.&#xD;
  &#xD;
            -  Any of the following clinical laboratory test results at the Screening Visit or&#xD;
               Check-in (Day -1), which can be confirmed by a single repeat measurement, if deemed&#xD;
               necessary:&#xD;
  &#xD;
                 -  AST or ALT &gt;ULN.&#xD;
  &#xD;
                 -  Total bilirubin &gt;ULN. If Gilbert's syndrome is suspected, total bilirubin &gt;ULN is&#xD;
                    acceptable if the conjugated or direct bilirubin fraction is &lt;20% of total&#xD;
                    bilirubin.&#xD;
  &#xD;
          Exclusion Criteria for Part C:&#xD;
  &#xD;
            -  Any of the following clinical laboratory test results at the Screening Visit or&#xD;
               Check-in (Day -1), as assessed by the central laboratory and confirmed by a single&#xD;
               repeat measurement, if deemed necessary:&#xD;
  &#xD;
                 -  AST or ALT ≥2 × ULN.&#xD;
  &#xD;
                 -  Total bilirubin &gt;1.5 × ULN. If Gilbert's syndrome is suspected, total bilirubin&#xD;
                    &gt;1.5 × ULN is acceptable if the conjugated or direct bilirubin fraction is &lt;20%&#xD;
                    of total bilirubin.&#xD;
  &#xD;
            -  Female participants who are pregnant, breastfeeding, or planning to become pregnant&#xD;
               during IMP treatment or within 7 days after the last dose of IMP. Women of&#xD;
               childbearing potential must have a negative serum pregnancy test result at the&#xD;
               Screening Visit and a negative urine pregnancy test result at Check-in.&#xD;
  &#xD;
          [Note: Other inclusion and exclusion criteria as per protocol may apply.]&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Brandi Eckard</last_name>
      <phone>913-333-3000</phone>
      <email>beckard@drvince.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Overland Park, Kansas</name>
        <address>
          <city>Overland Park</city>
          <state>Kansas</state>
          <zip>66212</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metformin</mesh_term>
      <mesh_term>Itraconazole</mesh_term>
      <mesh_term>Carbamazepine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05965219
  org study id: CVL-231-HV-1010
  nct id: NCT05965219
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary purpose of the study is to evaluate the effect of itraconazole, a strong
        cytochrome P450 (CYP) 3A4 inhibitor, on the pharmacokinetics (PK) of emraclidine and
        metabolite CV-0000364 in Part A, the effect of carbamazepine, a strong CYP3A4 inducer, on the
        PK of emraclidine and metabolite CV-0000364 in Part B, and to evaluate the effect of
        emraclidine on the PK of metformin in Part C in healthy adult participants.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
  measure: Part B: Cmax of Emraclidine and its Metabolite CV-0000364
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
  measure: Part C: Cmax of Metformin
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
  measure: Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
  measure: Part B: AUC0-t of Emraclidine and its Metabolite CV-0000364
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
  measure: Part C: AUC0-t of Metformin
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
  measure: Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 15 in TP 2 of Part A
  measure: Part B: AUCinf of Emraclidine and its Metabolite CV-0000364
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 20 in TP 2 of Part B
  measure: Part C: AUCinf of Metformin
  time frame: Pre-dose and at multiple time points post-dose from Day 1 in TP 1 up to Day 11 in TP 2 of Part C
  measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Based on Severity
  time frame: From the first dose up to 1 month following last dose with investigational medicinal product (IMP) in each part of the study
  measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
  time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
  measure: Number of Participants With Clinically Significant Changes in Vital Sign Measurements
  time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
  measure: Number of Participants With Clinically Significant Changes in Laboratory Assessments
  time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
  measure: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
  time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
  measure: Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
  time frame: Up to end of treatment in each part of the study (up to an average of 15 days)
  description: The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for the severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
  arm group label: Part A: Emraclidine Followed by Itraconazole + Emraclidine
  arm group type: Experimental
  description: Participants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2.
  arm group label: Part B: Emraclidine Followed by Carbamazepine + Emraclidine
  arm group type: Experimental
  description: Participants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2.
  arm group label: Part C: Metformin Followed by Emraclidine + Metformin
  arm group type: Experimental
  description: Participants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2.
  intervention type: Drug
  intervention name: Emraclidine
  description: Emraclidine tablets.
  arm group label: Part A: Emraclidine Followed by Itraconazole + Emraclidine
  arm group label: Part B: Emraclidine Followed by Carbamazepine + Emraclidine
  arm group label: Part C: Metformin Followed by Emraclidine + Metformin
  intervention type: Drug
  intervention name: Itraconazole
  description: Itraconazole oral solution.
  arm group label: Part A: Emraclidine Followed by Itraconazole + Emraclidine
  other name: Sporanox
  intervention type: Drug
  intervention name: Carbamazepine
  description: Carbamazepine tablets.
  arm group label: Part B: Emraclidine Followed by Carbamazepine + Emraclidine
  other name: Tegretol-XR
  intervention type: Drug
  intervention name: Metformin
  description: Metformin tablets.
  arm group label: Part C: Metformin Followed by Emraclidine + Metformin
  other name: Glucophage
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Brandi Eckard
  phone: 913-333-3000
  email: beckard@drvince.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Metformin
  mesh term: Itraconazole
  mesh term: Carbamazepine
  sharing ipd: No