<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/NCT03010475</url>
  </required_header>
  <id_info>
    <org_study_id>NN9924-4250</org_study_id>
    <secondary_id>2015-003908-23</secondary_id>
    <secondary_id>U1111-1173-8618</secondary_id>
    <nct_id>NCT03010475</nct_id>
  </id_info>
  <brief_title>A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects</brief_title>
  <official_title>A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects.</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>
      This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral&#xD;
      semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2017</start_date>
  <completion_date type="Actual">August 9, 2017</completion_date>
  <primary_completion_date type="Actual">June 4, 2017</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>Area under the furosemide plasma concentration-time curve</measure>
    <time_frame>day 1, day 7, day 54</time_frame>
    <description>Based on sampling between 0 and 12 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the rosuvastatin plasma concentration-time curve</measure>
    <time_frame>day 2, day 8, day 55</time_frame>
    <description>Based on sampling between 0 and 96 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed furosemide plasma concentration</measure>
    <time_frame>day 1, day 7, day 54</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed rosuvastatin plasma concentration</measure>
    <time_frame>day 2, day 8, day 55</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Diabetes</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Furosemide/Rosuvastatin/SNAC/Semaglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Furosemide</intervention_name>
    <description>Oral administration A total of three single doses.</description>
    <arm_group_label>Furosemide/Rosuvastatin/SNAC/Semaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Oral administration. A total of three single doses.</description>
    <arm_group_label>Furosemide/Rosuvastatin/SNAC/Semaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SNAC</intervention_name>
    <description>Oral administration. A total of five single doses.</description>
    <arm_group_label>Furosemide/Rosuvastatin/SNAC/Semaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Semaglutide</intervention_name>
    <description>Oral administration. Once daily.</description>
    <arm_group_label>Furosemide/Rosuvastatin/SNAC/Semaglutide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Informed consent obtained before any trial-related activities. Trial-related&#xD;
             activities are any procedures that are carried out as part of the trial, including&#xD;
             activities to determine suitability for the trial&#xD;
&#xD;
          -  Male or female, aged 18-65 years (both inclusive) at the time of signing informed&#xD;
             consent&#xD;
&#xD;
          -  Body mass index (BMI) between 20.0-29.9 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  Considered to be generally healthy based on the medical history, physical examination,&#xD;
             and the results of vital signs, electrocardiography and clinical laboratory tests&#xD;
             performed during the screening visit, as judged by the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker (defined as a subject who is smoking at least one cigarette or the equivalent&#xD;
             per day)&#xD;
&#xD;
          -  Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in&#xD;
             excess of 400 mL within the 3 months preceding screening&#xD;
&#xD;
          -  History of major surgical procedures involving the stomach potentially affecting&#xD;
             absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,&#xD;
             gastric bypass surgery)&#xD;
&#xD;
          -  Have personal or family history of myopathy&#xD;
&#xD;
          -  Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or&#xD;
             fibrate&#xD;
&#xD;
          -  Thyroid-Stimulating Hormone outside lower limit of normal minus 10 percent and upper&#xD;
             limit of normal plus 10 percent&#xD;
&#xD;
          -  Creatine kinase above 5 x upper limit of normal&#xD;
&#xD;
          -  Asian subject&#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>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Harrow</city>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>December 19, 2017</last_update_submitted>
  <last_update_submitted_qc>December 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2017</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>Furosemide</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>According to the Novo Nordisk disclosure commitment on novonordisk-trials.com</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03010475
org study id: NN9924-4250
secondary id: 2015-003908-23
secondary id: U1111-1173-8618
nct id: NCT03010475
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral
      semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the furosemide plasma concentration-time curve
time frame: day 1, day 7, day 54
description: Based on sampling between 0 and 12 hours
measure: Area under the rosuvastatin plasma concentration-time curve
time frame: day 2, day 8, day 55
description: Based on sampling between 0 and 96 hours
measure: Maximum observed furosemide plasma concentration
time frame: day 1, day 7, day 54
measure: Maximum observed rosuvastatin plasma concentration
time frame: day 2, day 8, day 55
arm group label: Furosemide/Rosuvastatin/SNAC/Semaglutide
arm group type: Experimental
intervention type: Drug
intervention name: Furosemide
description: Oral administration A total of three single doses.
arm group label: Furosemide/Rosuvastatin/SNAC/Semaglutide
intervention type: Drug
intervention name: Rosuvastatin
description: Oral administration. A total of three single doses.
arm group label: Furosemide/Rosuvastatin/SNAC/Semaglutide
intervention type: Drug
intervention name: SNAC
description: Oral administration. A total of five single doses.
arm group label: Furosemide/Rosuvastatin/SNAC/Semaglutide
intervention type: Drug
intervention name: Semaglutide
description: Oral administration. Once daily.
arm group label: Furosemide/Rosuvastatin/SNAC/Semaglutide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Furosemide
mesh term: Rosuvastatin Calcium
sharing ipd: Yes
ipd description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com