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/NCT06009237</url>
    </required_header>
    <id_info>
      <org_study_id>M24-227</org_study_id>
      <nct_id>NCT06009237</nct_id>
    </id_info>
    <brief_title>A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants</brief_title>
    <official_title>A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Subjects</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability&#xD;
        of ABBV-903 or placebo in healthy adult Japanese and Han Chinese subjects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">December 3, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 3, 2023</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) of ABBV-903</measure>
      <time_frame>Up to Day 4</time_frame>
      <description>Cmax of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time to Cmax (Tmax) of ABBV-903</measure>
      <time_frame>Up to Day 4</time_frame>
      <description>Tmax of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903</measure>
      <time_frame>Up to Day 4</time_frame>
      <description>Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Terminal Phase Elimination Half-life (t1/2) of ABBV-903</measure>
      <time_frame>Up to Day 4</time_frame>
      <description>Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903</measure>
      <time_frame>Up to Day 4</time_frame>
      <description>AUC0-t of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903</measure>
      <time_frame>Up to Day 4</time_frame>
      <description>AUC0-inf of ABBV-903 will be assessed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Baseline to Day 34</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>5</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Part 1: Han-Chinese Participants ABBV-903</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Han-Chinese participants will receive a single dose of ABBV-903.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1: Japanese Participants ABBV-903</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Japanese participants will receive a single dose of ABBV-903.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 1: Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single dose of Placebo for ABBV-903.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2: Japanese Participants ABBV-903</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Japanese participants will receive ABBV-903 daily for 10 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part 2: Japanese Participants Placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Japanese participants will receive placebo daily for 10 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ABBV-903</intervention_name>
      <description>Tablet; oral</description>
      <arm_group_label>Part 1: Han-Chinese Participants ABBV-903</arm_group_label>
      <arm_group_label>Part 1: Japanese Participants ABBV-903</arm_group_label>
      <arm_group_label>Part 2: Japanese Participants ABBV-903</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo for ABBV-903</intervention_name>
      <description>Tablet; oral</description>
      <arm_group_label>Part 1: Placebo</arm_group_label>
      <arm_group_label>Part 2: Japanese Participants Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Healthy Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive&#xD;
          at the time of screening.&#xD;
  &#xD;
            -  Han Chinese subject must be first-generation Han Chinese of full Chinese parentage&#xD;
               residing outside of China. Subjects must maintain a typical Chinese lifestyle,&#xD;
               including consuming a typical Chinese diet.&#xD;
  &#xD;
          OR&#xD;
  &#xD;
            -  Japanese subject must be first- or second generation Japanese of full Japanese&#xD;
               parentage. First-generation subjects will have been born in Japan to two parents and&#xD;
               four grandparents also born in Japan of full Japanese descent. Second-generation&#xD;
               subjects born outside of Japan must have two parents and four grandparents born in&#xD;
               Japan of full Japanese descent. All subjects must maintain a typical Japanese&#xD;
               lifestyle, including consuming a typical Japanese diet.&#xD;
  &#xD;
                 -  Body Mass Index (BMI) is &gt;= 18.0 to &lt;= 30.0 kg/m2 after rounding to the tenths&#xD;
                    decimal, at screening and upon initial confinement. BMI is calculated as weight&#xD;
                    in kg divided by the square of height measured in meters.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of any clinically significant illness/infection/major febrile illness,&#xD;
               hospitalization, as determined by the investigator, or any surgical procedure within&#xD;
               30 days prior to the first dose of study drug.&#xD;
  &#xD;
            -  Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other&#xD;
               than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma&#xD;
               orlocalized carcinoma in situ of the cervix.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</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>Anaheim Clinical Trials LLC /ID# 257033</name>
        <address>
          <city>Anaheim</city>
          <state>California</state>
          <zip>92801-2658</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>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ABBV-903</keyword>
    <keyword>Healthy Volunteers</keyword>
    <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/NCT06009237
  org study id: M24-227
  nct id: NCT06009237
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability
        of ABBV-903 or placebo in healthy adult Japanese and Han Chinese subjects.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Maximum observed plasma concentration (Cmax) of ABBV-903
  time frame: Up to Day 4
  description: Cmax of ABBV-903 will be assessed.
  measure: Time to Cmax (Tmax) of ABBV-903
  time frame: Up to Day 4
  description: Tmax of ABBV-903 will be assessed.
  measure: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903
  time frame: Up to Day 4
  description: Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed.
  measure: Terminal Phase Elimination Half-life (t1/2) of ABBV-903
  time frame: Up to Day 4
  description: Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
  measure: Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903
  time frame: Up to Day 4
  description: AUC0-t of ABBV-903 will be assessed.
  measure: AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903
  time frame: Up to Day 4
  description: AUC0-inf of ABBV-903 will be assessed.
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Baseline to Day 34
  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: Han-Chinese Participants ABBV-903
  arm group type: Experimental
  description: Han-Chinese participants will receive a single dose of ABBV-903.
  arm group label: Part 1: Japanese Participants ABBV-903
  arm group type: Experimental
  description: Japanese participants will receive a single dose of ABBV-903.
  arm group label: Part 1: Placebo
  arm group type: Experimental
  description: Participants will receive a single dose of Placebo for ABBV-903.
  arm group label: Part 2: Japanese Participants ABBV-903
  arm group type: Experimental
  description: Japanese participants will receive ABBV-903 daily for 10 days.
  arm group label: Part 2: Japanese Participants Placebo
  arm group type: Experimental
  description: Japanese participants will receive placebo daily for 10 days.
  intervention type: Drug
  intervention name: ABBV-903
  description: Tablet; oral
  arm group label: Part 1: Han-Chinese Participants ABBV-903
  arm group label: Part 1: Japanese Participants ABBV-903
  arm group label: Part 2: Japanese Participants ABBV-903
  intervention type: Drug
  intervention name: Placebo for ABBV-903
  description: Tablet; oral
  arm group label: Part 1: Placebo
  arm group label: Part 2: Japanese Participants Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  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: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  sharing ipd: No