<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/NCT02243098</url>
  </required_header>
  <id_info>
    <org_study_id>NN9535-3818</org_study_id>
    <secondary_id>2013-001288-22</secondary_id>
    <secondary_id>U1111-1140-8551</secondary_id>
    <nct_id>NCT02243098</nct_id>
  </id_info>
  <brief_title>Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects</brief_title>
  <official_title>An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial is conducted in Europe. The aim of the trial is to investigate the influence of&#xD;
      semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single&#xD;
      doses of atorvastatin and digoxin in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2014</start_date>
  <completion_date type="Actual">April 7, 2015</completion_date>
  <primary_completion_date type="Actual">April 7, 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the atorvastatin plasma concentration-time curve</measure>
    <time_frame>From time 0 to 72 hours after a single dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the digoxin plasma concentration-time curve</measure>
    <time_frame>From time 0 to 120 hours after a single dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed atorvastatin plasma concentration</measure>
    <time_frame>From time 0 to 72 hours after a single dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed digoxin plasma concentration</measure>
    <time_frame>From time 0 to 120 hours after a single dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of treatment emergent AEs (TEAEs)</measure>
    <time_frame>From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Diabetes</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Semaglutide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period.</description>
    <arm_group_label>Semaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>digoxin</intervention_name>
    <description>Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.</description>
    <arm_group_label>Semaglutide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>atorvastatin</intervention_name>
    <description>Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.</description>
    <arm_group_label>Semaglutide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female, age between 18 and 55 years (both inclusive) at the time of signing&#xD;
             informed consent&#xD;
&#xD;
          -  Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female who is pregnant, breast-feeding or intends to become pregnant or is of&#xD;
             child-bearing potential and not using an adequate contraceptive method. Women of&#xD;
             child-bearing potential must use an effective method of birth control throughout the&#xD;
             trial including the 5 weeks follow-up period. Only highly effective methods of birth&#xD;
             control are accepted (i.e. one that results in less than 1% per year failure rate when&#xD;
             used consistently and correctly such as implants, injectables, combined oral&#xD;
             contraceptives, some intrauterine device), or sexual abstinence or vasectomised&#xD;
             partner&#xD;
&#xD;
          -  Any clinically significant disease history, in the opinion of the investigator, or&#xD;
             systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic,&#xD;
             neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases&#xD;
&#xD;
          -  Use of prescription or non-prescription systemic or topical medicinal products&#xD;
             (including routine or non-routine vitamins or herbal supplements, but excluding&#xD;
             paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the&#xD;
             medicinal product, whichever is longest) prior to Visit 2 (first dose administration)&#xD;
&#xD;
          -  History of drug/chemical substance abuse within 1 year from screening, or a positive&#xD;
             result in the urine drug test&#xD;
&#xD;
          -  History of alcohol abuse within 1 year from screening, or a positive result in the&#xD;
             alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of&#xD;
             alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass&#xD;
             (120 mL) of wine, or 20 mL spirits)&#xD;
&#xD;
          -  Smoking in the last 3 months prior to screening or a positive nicotine test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Global Clinical Registry (GCR, 1452)</last_name>
    <role>Study Director</role>
    <affiliation>Novo Nordisk A/S</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novo Nordisk Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <results_reference>
    <citation>Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6.</citation>
    <PMID>28349387</PMID>
  </results_reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 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>Digoxin</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02243098
org study id: NN9535-3818
secondary id: 2013-001288-22
secondary id: U1111-1140-8551
nct id: NCT02243098
lead sponsor: 
has dmc: No
The trial is conducted in Europe. The aim of the trial is to investigate the influence of
      semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single
      doses of atorvastatin and digoxin in healthy subjects.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Area under the atorvastatin plasma concentration-time curve
time frame: From time 0 to 72 hours after a single dose
measure: Area under the digoxin plasma concentration-time curve
time frame: From time 0 to 120 hours after a single dose
measure: Maximum observed atorvastatin plasma concentration
time frame: From time 0 to 72 hours after a single dose
measure: Maximum observed digoxin plasma concentration
time frame: From time 0 to 120 hours after a single dose
measure: Number of treatment emergent AEs (TEAEs)
time frame: From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline)
arm group label: Semaglutide
arm group type: Experimental
intervention type: Drug
intervention name: semaglutide
description: Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period.
arm group label: Semaglutide
intervention type: Drug
intervention name: digoxin
description: Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.
arm group label: Semaglutide
intervention type: Drug
intervention name: atorvastatin
description: Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.
arm group label: Semaglutide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Global Clinical Registry (GCR, 1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: Germany
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
citation: Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6.
PMID: 28349387
responsible party type: Sponsor
mesh term: Digoxin
mesh term: Atorvastatin