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/NCT05996874</url>
    </required_header>
    <id_info>
      <org_study_id>NN9924-4977</org_study_id>
      <secondary_id>U1111-1281-4819</secondary_id>
      <secondary_id>2022-002848-52</secondary_id>
      <nct_id>NCT05996874</nct_id>
    </id_info>
    <brief_title>A Research Study Comparing the Effect of Different Dosing Conditions on Blood Levels of Semaglutide in a New Tablet Composition in Healthy Participants</brief_title>
    <official_title>Investigation of the Effect of Dosing Conditions on the Pharmacokinetics of New Oral Semaglutide Formulation in Healthy Participants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Novo Nordisk A/S</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Novo Nordisk A/S</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, a known medicine called 'semaglutide' will be tested in a new tablet version.&#xD;
        The medicine will be tested in healthy men to explore the effect of different water volumes&#xD;
        and tablet-meal delays on blood levels of semaglutide after 10 days of oral administration.&#xD;
        Semaglutide tablets, under the brand name Rybelsus, are approved in the EU and USA for the&#xD;
        treatment of type 2 diabetes. Participants will get a daily treatment with dose 1 new oral&#xD;
        semaglutide tablet for 5 days followed by another 5 days with a daily treatment of dose 2 new&#xD;
        oral semaglutide tablet. Participants will get one tablet each day for 10 days. The tablet&#xD;
        should be taken in the morning on an empty stomach with either 50 milliliter (mL) or 120mL&#xD;
        water, after an overnight fast of at least 6 hours (no food or drinks). Water is not allowed&#xD;
        from 2 hours before dosing. A predefined breakfast will be served either 30, 60 or 120&#xD;
        minutes after taking tablet, depending on the treatment received. Breakfast will need to be&#xD;
        eaten within 30 minutes. Which treatment participants will get is decided by chance. The&#xD;
        study will last for about 11 weeks. This will include a screening period (up to 28 days), a&#xD;
        treatment period (10 days) and a follow-up visit (at least 5 weeks after the last dose).&#xD;
        Participants should not take any prescription or non-prescription medicines or herbal&#xD;
        products (including St John's wort) within 14 days prior to the screening visit and until the&#xD;
        follow-up visit, except for routine vitamins, medicines applied on the skin and occasional&#xD;
        use of paracetamol (a mild pain killer). No oral medication can be taken from 2 hours before&#xD;
        and, depending on the group participants are in, until 30, 60 or 120 minutes after each&#xD;
        dosing with semaglutide.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 12, 2023</start_date>
    <completion_date type="Anticipated">May 24, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 21, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AUC0-24h,sema,Day10: Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing</measure>
      <time_frame>From 0 to 24 hours after dosing on day 10</time_frame>
      <description>Measured in hour*nanomoles per liter (h*nmol/L).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax,0-24h,sema,Day10: Maximum semaglutide plasma concentration after the 10th dosing</measure>
      <time_frame>From 0 to 24 hours after dosing on day 10</time_frame>
      <description>Measured in nanomoles per liter (nmol/L).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>tmax,0-24h,sema,Day10: Time to maximum semaglutide plasma concentration after the 10th dosing</measure>
      <time_frame>From 0 to 24 hours after dosing on day 10</time_frame>
      <description>Measured in hours (h).</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Healthy Participants</condition>
    <arm_group>
      <arm_group_label>Semaglutide: 50 mL water and 30 minutes post-dose fasting</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 30 minutes post-dose fasting.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Semaglutide: 120 mL water and 30 minutes post-dose fasting</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by dose 2 of oral semaglutide D for another 5 days with 120 mL water and 30 minutes post-dose fasting.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Semaglutide: 50 mL water and 60 minutes post-dose fasting</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 60 minutes post-dose fasting.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Semaglutide: 120 mL water and 60 minutes post-dose fasting</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 120 mL water and 60 minutes post-dose fasting.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Semaglutide: 50 mL water and 120 minutes post-dose fasting</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 120 minutes post-dose fasting.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Semaglutide: 120 mL water and 120 minutes post-dose fasting</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 120 mL water and 120 minutes post-dose fasting.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Semaglutide</intervention_name>
      <description>Participants will receive Dose 1 oral semaglutide D for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days.</description>
      <arm_group_label>Semaglutide: 120 mL water and 120 minutes post-dose fasting</arm_group_label>
      <arm_group_label>Semaglutide: 120 mL water and 30 minutes post-dose fasting</arm_group_label>
      <arm_group_label>Semaglutide: 120 mL water and 60 minutes post-dose fasting</arm_group_label>
      <arm_group_label>Semaglutide: 50 mL water and 120 minutes post-dose fasting</arm_group_label>
      <arm_group_label>Semaglutide: 50 mL water and 30 minutes post-dose fasting</arm_group_label>
      <arm_group_label>Semaglutide: 50 mL water and 60 minutes post-dose fasting</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body mass index (BMI) between 18.5 and 29.9 kilograms per meter square (kg/m^2) (both&#xD;
               inclusive)&#xD;
  &#xD;
            -  Considered to be generally healthy based on the medical history, physical examination,&#xD;
               and the results of vital signs, electrocardiogram and clinical laboratory tests&#xD;
               performed during the screening visit, as judged by the investigator&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Glycated Hemoglobin (HbA1c) greater than or equal to (&gt;=) 6.5 percent (%) (48&#xD;
               millimoles per mole [mmol/mol]) at screening&#xD;
  &#xD;
            -  Use of tobacco and nicotine products, defined as any of the below:&#xD;
  &#xD;
                 1. Smoking more than 5 cigarettes or the equivalent per day&#xD;
  &#xD;
                 2. Not willing to refrain from smoking and use of nicotine substitute products&#xD;
                    within 48 hours prior to and during the inpatient periods&#xD;
  &#xD;
            -  Presence of clinically significant gastrointestinal disorders potentially affecting&#xD;
               absorption of drugs and/or nutrients, as judged by the investigator&#xD;
  &#xD;
            -  Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or&#xD;
               medullary thyroid carcinoma&#xD;
  &#xD;
            -  History of major surgical procedures involving the stomach potentially affecting&#xD;
               absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy,&#xD;
               gastric bypass surgery) or current presence of gastrointestinal implant&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Clinical Transparency (dept. 2834)</last_name>
      <role>Study Director</role>
      <affiliation>Novo Nordisk A/S</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Novo Nordisk</last_name>
      <phone>(+1) 866-867-7178</phone>
      <email>clinicaltrials@novonordisk.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Novo Nordisk Investigational Site</name>
        <address>
          <city>Neuss</city>
          <zip>41460</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.</ipd_description>
      <ipd_url>http://novonordisk-trials.com</ipd_url>
    </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/NCT05996874
  org study id: NN9924-4977
  secondary id: U1111-1281-4819
  secondary id: 2022-002848-52
  nct id: NCT05996874
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, a known medicine called 'semaglutide' will be tested in a new tablet version.
        The medicine will be tested in healthy men to explore the effect of different water volumes
        and tablet-meal delays on blood levels of semaglutide after 10 days of oral administration.
        Semaglutide tablets, under the brand name Rybelsus, are approved in the EU and USA for the
        treatment of type 2 diabetes. Participants will get a daily treatment with dose 1 new oral
        semaglutide tablet for 5 days followed by another 5 days with a daily treatment of dose 2 new
        oral semaglutide tablet. Participants will get one tablet each day for 10 days. The tablet
        should be taken in the morning on an empty stomach with either 50 milliliter (mL) or 120mL
        water, after an overnight fast of at least 6 hours (no food or drinks). Water is not allowed
        from 2 hours before dosing. A predefined breakfast will be served either 30, 60 or 120
        minutes after taking tablet, depending on the treatment received. Breakfast will need to be
        eaten within 30 minutes. Which treatment participants will get is decided by chance. The
        study will last for about 11 weeks. This will include a screening period (up to 28 days), a
        treatment period (10 days) and a follow-up visit (at least 5 weeks after the last dose).
        Participants should not take any prescription or non-prescription medicines or herbal
        products (including St John's wort) within 14 days prior to the screening visit and until the
        follow-up visit, except for routine vitamins, medicines applied on the skin and occasional
        use of paracetamol (a mild pain killer). No oral medication can be taken from 2 hours before
        and, depending on the group participants are in, until 30, 60 or 120 minutes after each
        dosing with semaglutide.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: AUC0-24h,sema,Day10: Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing
  time frame: From 0 to 24 hours after dosing on day 10
  description: Measured in hour*nanomoles per liter (h*nmol/L).
  measure: Cmax,0-24h,sema,Day10: Maximum semaglutide plasma concentration after the 10th dosing
  time frame: From 0 to 24 hours after dosing on day 10
  description: Measured in nanomoles per liter (nmol/L).
  measure: tmax,0-24h,sema,Day10: Time to maximum semaglutide plasma concentration after the 10th dosing
  time frame: From 0 to 24 hours after dosing on day 10
  description: Measured in hours (h).
  arm group label: Semaglutide: 50 mL water and 30 minutes post-dose fasting
  arm group type: Experimental
  description: Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 30 minutes post-dose fasting.
  arm group label: Semaglutide: 120 mL water and 30 minutes post-dose fasting
  arm group type: Experimental
  description: Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by dose 2 of oral semaglutide D for another 5 days with 120 mL water and 30 minutes post-dose fasting.
  arm group label: Semaglutide: 50 mL water and 60 minutes post-dose fasting
  arm group type: Experimental
  description: Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 60 minutes post-dose fasting.
  arm group label: Semaglutide: 120 mL water and 60 minutes post-dose fasting
  arm group type: Experimental
  description: Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 120 mL water and 60 minutes post-dose fasting.
  arm group label: Semaglutide: 50 mL water and 120 minutes post-dose fasting
  arm group type: Experimental
  description: Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 50 mL water and 120 minutes post-dose fasting.
  arm group label: Semaglutide: 120 mL water and 120 minutes post-dose fasting
  arm group type: Experimental
  description: Participants will receive oral semaglutide D once daily for 10 days. Dose 1 of oral semaglutide D will be administered for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days with 120 mL water and 120 minutes post-dose fasting.
  intervention type: Drug
  intervention name: Semaglutide
  description: Participants will receive Dose 1 oral semaglutide D for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days.
  arm group label: Semaglutide: 120 mL water and 120 minutes post-dose fasting
  arm group label: Semaglutide: 120 mL water and 30 minutes post-dose fasting
  arm group label: Semaglutide: 120 mL water and 60 minutes post-dose fasting
  arm group label: Semaglutide: 50 mL water and 120 minutes post-dose fasting
  arm group label: Semaglutide: 50 mL water and 30 minutes post-dose fasting
  arm group label: Semaglutide: 50 mL water and 60 minutes post-dose fasting
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Clinical Transparency (dept. 2834)
  role: Study Director
  affiliation: Novo Nordisk A/S
  last name: Novo Nordisk
  phone: (+1) 866-867-7178
  email: clinicaltrials@novonordisk.com
  facility: 
  status: Recruiting
  country: Germany
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
  ipd url: http://novonordisk-trials.com