<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/NCT02249871</url>
  </required_header>
  <id_info>
    <org_study_id>NN9924-4141</org_study_id>
    <secondary_id>2013-005513-12</secondary_id>
    <secondary_id>U1111-1151-5077</secondary_id>
    <nct_id>NCT02249871</nct_id>
  </id_info>
  <brief_title>Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects</brief_title>
  <official_title>A Trial Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide 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>
      This trial is conducted in Europe. The aim of this trial is to investigate the influence of&#xD;
      omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral&#xD;
      semaglutide in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2014</start_date>
  <completion_date type="Actual">April 1, 2015</completion_date>
  <primary_completion_date type="Actual">April 1, 2015</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>Area under the semaglutide plasma concentration time curve</measure>
    <time_frame>From time 0 to 24 hours after the 10th daily dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the SNAC plasma concentration time curve</measure>
    <time_frame>From time 0 to 24 hours after the 10th daily dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycaemic episodes</measure>
    <time_frame>From first dosing (Day 1) to completion of the follow-up visit (Day 43 (± 2 days))</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</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>
  <arm_group>
    <arm_group_label>Semaglutide + Omeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>All subjects will be treated for 10 consecutive days including dose escalation, with 5 days on 5 mg oral semaglutide followed by 5 days on 10 mg oral semaglutide.</description>
    <arm_group_label>Semaglutide</arm_group_label>
    <arm_group_label>Semaglutide + Omeprazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omeprazole</intervention_name>
    <description>Will be given daily with oral semaglutide.</description>
    <arm_group_label>Semaglutide + Omeprazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age 18-75 years (both inclusive) at time of signing informed consent&#xD;
&#xD;
          -  Body mass index of 18.5-29.9 kg/m^2 (both inclusive)&#xD;
&#xD;
          -  A good general health based on medical history, physical examination, and results of&#xD;
             vital signs, electrocardiogram and laboratory safety tests performed during the&#xD;
             screening visit, as judged by the investigator&#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 adequate contraceptive methods. Female of child&#xD;
             bearing potential must use effective methods of birth control for the duration of the&#xD;
             trial and for 5 weeks following last dose. Only highly effective methods of birth&#xD;
             control are accepted (i.e., one that results in a less than 1% per year failure rate&#xD;
             when used consistently and correctly, such as implants, injectables, combined oral&#xD;
             contraceptives, and some intrauterine devices)&#xD;
&#xD;
          -  History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease&#xD;
&#xD;
          -  Hypertension (defined as sitting systolic blood pressure above or equal to 140 mmHg&#xD;
             and/or diastolic blood pressure above or equal to 90 mmHg). If white-coat hypertension&#xD;
             is suspected at the screening visit a repeated measurement is allowed&#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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 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>Baekdal TA, Breitschaft A, Navarria A, Hansen CW. A randomized study investigating the effect of omeprazole on the pharmacokinetics of oral semaglutide. Expert Opin Drug Metab Toxicol. 2018 Aug;14(8):869-877. doi: 10.1080/17425255.2018.1488965. Epub 2018 Jun 30.</citation>
    <PMID>29897249</PMID>
  </results_reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2018</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>Omeprazole</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/NCT02249871
org study id: NN9924-4141
secondary id: 2013-005513-12
secondary id: U1111-1151-5077
nct id: NCT02249871
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to investigate the influence of
      omeprazole on the pharmacokinetics (the exposure of the trial drug in the body) of oral
      semaglutide in healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the semaglutide plasma concentration time curve
time frame: From time 0 to 24 hours after the 10th daily dose
measure: Area under the SNAC plasma concentration time curve
time frame: From time 0 to 24 hours after the 10th daily dose
measure: Number of hypoglycaemic episodes
time frame: From first dosing (Day 1) to completion of the follow-up visit (Day 43 (± 2 days))
arm group label: Semaglutide
arm group type: Experimental
arm group label: Semaglutide + Omeprazole
arm group type: Experimental
intervention type: Drug
intervention name: semaglutide
description: All subjects will be treated for 10 consecutive days including dose escalation, with 5 days on 5 mg oral semaglutide followed by 5 days on 10 mg oral semaglutide.
arm group label: Semaglutide
arm group label: Semaglutide + Omeprazole
intervention type: Drug
intervention name: Omeprazole
description: Will be given daily with oral semaglutide.
arm group label: Semaglutide + Omeprazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 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: Baekdal TA, Breitschaft A, Navarria A, Hansen CW. A randomized study investigating the effect of omeprazole on the pharmacokinetics of oral semaglutide. Expert Opin Drug Metab Toxicol. 2018 Aug;14(8):869-877. doi: 10.1080/17425255.2018.1488965. Epub 2018 Jun 30.
PMID: 29897249
responsible party type: Sponsor
mesh term: Omeprazole