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/NCT06024239</url>
    </required_header>
    <id_info>
      <org_study_id>M23-893</org_study_id>
      <nct_id>NCT06024239</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate Adverse Events ABBV-932 and How Oral ABBV-932 Capsules Move Through the Body in Healthy Adults and Participants With Generalized Anxiety Disorder (GAD)</brief_title>
    <official_title>A Multiple Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-932 in Healthy Adult Subjects and Patients With Generalized Anxiety Disorder (GAD)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AbbVie</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AbbVie</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to assess the pharmacokinetics, safety, and tolerability&#xD;
        following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants&#xD;
        and patients with Generalized Anxiety Disorder (GAD).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">March 12, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 12, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
      <time_frame>Up to Day 28</time_frame>
      <description>Cmax will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Cmax (Tmax)</measure>
      <time_frame>Up to Day 28</time_frame>
      <description>Tmax will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)</measure>
      <time_frame>Up to Day 28</time_frame>
      <description>Ctrough will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)</measure>
      <time_frame>Up to Day 28</time_frame>
      <description>AUCtau will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Baseline to Day 115</time_frame>
      <description>An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">56</enrollment>
    <condition>Healthy Volunteers Patients With Generalized Anxiety Disorder (GAD)</condition>
    <arm_group>
      <arm_group_label>Part 1, ABBV-932</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ABBV-932 once daily (QD) for 14 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1, Placebo for ABBV-932</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive placebo for ABBV-932 QD for 14 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2, ABBV-932</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ABBV-932 QD for 28 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo for ABBV-932</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive placebo for ABBV-932 QD for 28 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ABBV-932</intervention_name>
      <description>Capsule; oral</description>
      <arm_group_label>Part 1, ABBV-932</arm_group_label>
      <arm_group_label>Part 2, ABBV-932</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo for ABBV-932</intervention_name>
      <description>Capsule; oral</description>
      <arm_group_label>Part 1, Placebo for ABBV-932</arm_group_label>
      <arm_group_label>Placebo for ABBV-932</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body mass index (BMI) is &gt;= 18.0 to &lt;= 32.0 kg/m2 after rounding to the tenths&#xD;
               decimal.&#xD;
  &#xD;
            -  For healthy volunteer cohort:&#xD;
  &#xD;
                 -  Individuals between 18 and 65 years of age inclusive at the time of screening.&#xD;
  &#xD;
            -  For patients with generalized anxiety disorder (GAD) cohort(s): Patients with GAD&#xD;
               between 18 and 65 years of age, inclusive at time of screening meet the following&#xD;
               criteria:&#xD;
  &#xD;
                 -  Patients with DSM-5 Primary diagnosis of GAD as confirmed by MINI, and a HAM-A&#xD;
                    score ≥ 15 (at least moderate anxiety) and CGI-Severity Score ≥ 3 (mildly ill) at&#xD;
                    screening.&#xD;
  &#xD;
            -  Body mass index (BMI) is &gt;= 18.0 to &lt;= 32.0 kg/m2 after rounding to the tenths&#xD;
               decimal.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of any clinically significant illness/infection/major febrile illness,&#xD;
               hospitalization, or any surgical procedure within 30 days prior to the first dose of&#xD;
               study drug.&#xD;
  &#xD;
            -  History of major depressive episode within the past 3-months.&#xD;
  &#xD;
            -  Lifetime history of psychiatric illness meeting DSM-5-TR criteria (except for GAD and&#xD;
               MDD).&#xD;
  &#xD;
            -  History of clinically significant substance use disorder (meets DSM-5-TR criteria) in&#xD;
               the past 6-months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Months</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ABBVIE INC.</last_name>
      <role>Study Director</role>
      <affiliation>AbbVie</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ABBVIE CALL CENTER</last_name>
      <phone>844-663-3742</phone>
      <email>abbvieclinicaltrials@abbvie.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Acpru /Id# 255945</name>
        <address>
          <city>Grayslake</city>
          <state>Illinois</state>
          <zip>60030</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.abbvieclinicaltrials.com/study/?id=M23-893</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ABBV-932</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_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/NCT06024239
  org study id: M23-893
  nct id: NCT06024239
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to assess the pharmacokinetics, safety, and tolerability
        following multiple ascending oral doses of ABBV-932 or placebo in healthy adult participants
        and patients with Generalized Anxiety Disorder (GAD).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Maximum Observed Plasma Concentration (Cmax)
  time frame: Up to Day 28
  description: Cmax will be assessed.
  measure: Time to Cmax (Tmax)
  time frame: Up to Day 28
  description: Tmax will be assessed.
  measure: Plasma Concentrations at Pre-dose or at the End of a Dosing Interval (Ctrough)
  time frame: Up to Day 28
  description: Ctrough will be assessed.
  measure: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau)
  time frame: Up to Day 28
  description: AUCtau will be assessed.
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Baseline to Day 115
  description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
  arm group label: Part 1, ABBV-932
  arm group type: Experimental
  description: Participants will receive ABBV-932 once daily (QD) for 14 days.
  arm group label: Part 1, Placebo for ABBV-932
  arm group type: Experimental
  description: Participants will receive placebo for ABBV-932 QD for 14 days.
  arm group label: Part 2, ABBV-932
  arm group type: Experimental
  description: Participants will receive ABBV-932 QD for 28 days.
  arm group label: Placebo for ABBV-932
  arm group type: Experimental
  description: Participants will receive placebo for ABBV-932 QD for 28 days.
  intervention type: Drug
  intervention name: ABBV-932
  description: Capsule; oral
  arm group label: Part 1, ABBV-932
  arm group label: Part 2, ABBV-932
  intervention type: Drug
  intervention name: Placebo for ABBV-932
  description: Capsule; oral
  arm group label: Part 1, Placebo for ABBV-932
  arm group label: Placebo for ABBV-932
  criteria: 
  gender: All
  minimum age: 18 Months
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: ABBVIE INC.
  role: Study Director
  affiliation: AbbVie
  last name: ABBVIE CALL CENTER
  phone: 844-663-3742
  email: abbvieclinicaltrials@abbvie.com
  facility: 
  country: United States
  url: https://www.abbvieclinicaltrials.com/study/?id=M23-893
  description: Related Info
  responsible party type: Sponsor
  mesh term: Anxiety Disorders
  sharing ipd: No