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/NCT06004180</url>
    </required_header>
    <id_info>
      <org_study_id>20399A</org_study_id>
      <nct_id>NCT06004180</nct_id>
    </id_info>
    <brief_title>A Trial Investigating Lu AF28996 in Adult Japanese Participants With Parkinson's Disease (PD)</brief_title>
    <official_title>Interventional, Exploratory, Open-label Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Properties of Lu AF28996 in Japanese Men and Women With Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>H. Lundbeck A/S</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>H. Lundbeck A/S</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This trial will evaluate the effects of Lu AF28996 in adult Japanese men and women with&#xD;
        Parkinson's disease (PD). The main goals of the trial are to learn more about a) the safety&#xD;
        and tolerability of Lu AF28996 (any new or worsening medical issues the participants have&#xD;
        with treatment), and b) the pharmacokinetic parameters of Lu AF28996 (how the drug is&#xD;
        absorbed, distributed, and processed by the body). Participants will take Lu AF28996 capsules&#xD;
        orally once a day (OD). The participants will start with a low dose of Lu AF28996, which will&#xD;
        be increased gradually over a period of 2 weeks, and then decreased gradually over a period&#xD;
        of about 2 weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">November 21, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 21, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
      <time_frame>From the day of first dose of study drug (Day 1) up to Day 35</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996</measure>
      <time_frame>Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-Time Curve From Zero to 24 Hours Post-Dose (AUC0-24h) of Lu AF28996</measure>
      <time_frame>Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax) of Lu AF28996</measure>
      <time_frame>Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Oral Clearance (CL/F) of Lu AF28996</measure>
      <time_frame>Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16</time_frame>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">6</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Lu AF28996</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ascending oral doses of Lu AF28996 OD for 14 days (Day 1 to Day 14). From Day 15, the participant will initiate down-titration of Lu AF28996 as per investigator's judgement.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Lu AF28996</intervention_name>
      <description>Hard capsule, orally, per schedule specified in the arm description.</description>
      <arm_group_label>Lu AF28996</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The participant is diagnosed with idiopathic PD (consistent with the United Kingdom&#xD;
               Parkinson's Disease Society Brain Bank Criteria for the Diagnosis of Parkinson's&#xD;
               Disease) and should not have more than 1 first-degree relative with PD.&#xD;
  &#xD;
            -  The participant's Modified Hoehn and Yahr score is ≤3 in the ON state and ≤4 in the&#xD;
               OFF state.&#xD;
  &#xD;
            -  The participant experiences well-recognizable and predictable motor fluctuations (≥1.5&#xD;
               hours of OFF-periods in the awake time, predictable morning OFF episodes included)&#xD;
               causing clinically significant disability during the 7-week Screening Period.&#xD;
  &#xD;
            -  The participant currently has a good response to levodopa and has been receiving a&#xD;
               stable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitor&#xD;
               therapy) ≥4 weeks prior to screening.&#xD;
  &#xD;
            -  The participant is Japanese, defined as having four Japanese grandparents and being&#xD;
               born in Japan.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The participant has or had one or more of the following conditions that are considered&#xD;
               clinically relevant in the context of the study; other neurological disorder,&#xD;
               psychiatric disorder, seizure disorder or encephalopathy, respiratory disease, hepatic&#xD;
               impairment or renal insufficiency, metabolic disorder, endocrinological disorder,&#xD;
               hematological disorder, infectious disorder, any clinically significant immunological&#xD;
               condition, or a history of narrow-angle glaucoma.&#xD;
  &#xD;
            -  The participant has a positive test result for SARS-CoV-2 at the Baseline Visit.&#xD;
  &#xD;
            -  The participant has undergone a neurosurgical intervention for PD (such as&#xD;
               pallidotomy, thalamotomy, fetal or stem cell transplantation or deep brain&#xD;
               stimulation).&#xD;
  &#xD;
          Note: Other inclusion and exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Email contact via H. Lundbeck A/S</last_name>
      <role>Study Director</role>
      <affiliation>LundbeckClinicalTrials@Lundbeck.com</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Email contact via H. Lundbeck A/S</last_name>
      <phone>+45 36301311</phone>
      <email>LundbeckClinicalTrials@Lundbeck.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ehime University Hospital</name>
        <address>
          <city>Toon</city>
          <state>Ehime</state>
          <zip>791-0295</zip>
          <country>Japan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Japan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 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>Parkinson Disease</mesh_term>
    </condition_browse>
    <!-- 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/NCT06004180
  org study id: 20399A
  nct id: NCT06004180
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This trial will evaluate the effects of Lu AF28996 in adult Japanese men and women with
        Parkinson's disease (PD). The main goals of the trial are to learn more about a) the safety
        and tolerability of Lu AF28996 (any new or worsening medical issues the participants have
        with treatment), and b) the pharmacokinetic parameters of Lu AF28996 (how the drug is
        absorbed, distributed, and processed by the body). Participants will take Lu AF28996 capsules
        orally once a day (OD). The participants will start with a low dose of Lu AF28996, which will
        be increased gradually over a period of 2 weeks, and then decreased gradually over a period
        of about 2 weeks.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
  time frame: From the day of first dose of study drug (Day 1) up to Day 35
  measure: Area Under the Plasma Concentration-Time Curve From Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AF28996
  time frame: Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16
  measure: Area Under the Plasma Concentration-Time Curve From Zero to 24 Hours Post-Dose (AUC0-24h) of Lu AF28996
  time frame: Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16
  measure: Maximum Observed Plasma Concentration (Cmax) of Lu AF28996
  time frame: Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16
  measure: Oral Clearance (CL/F) of Lu AF28996
  time frame: Day 1 to Day 14 (0 [predose] to 15 hours postdose); Day 15 (24 hours post the Day 14 dose and before dosing on Day 15); and Day 16
  arm group label: Lu AF28996
  arm group type: Experimental
  description: Participants will receive ascending oral doses of Lu AF28996 OD for 14 days (Day 1 to Day 14). From Day 15, the participant will initiate down-titration of Lu AF28996 as per investigator's judgement.
  intervention type: Drug
  intervention name: Lu AF28996
  description: Hard capsule, orally, per schedule specified in the arm description.
  arm group label: Lu AF28996
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Email contact via H. Lundbeck A/S
  role: Study Director
  affiliation: LundbeckClinicalTrials@Lundbeck.com
  last name: Email contact via H. Lundbeck A/S
  phone: +45 36301311
  email: LundbeckClinicalTrials@Lundbeck.com
  facility: 
  country: Japan
  responsible party type: Sponsor
  mesh term: Parkinson Disease