<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/NCT02231684</url>
  </required_header>
  <id_info>
    <org_study_id>NN9535-3687</org_study_id>
    <secondary_id>2013-004566-34</secondary_id>
    <secondary_id>U1111-1149-3980</secondary_id>
    <nct_id>NCT02231684</nct_id>
  </id_info>
  <brief_title>Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide</brief_title>
  <official_title>A Randomised, Single Centre, Two Period, Incomplete Cross Over Trial in Healthy Subjects Investigating the Pharmacokinetics of Subcutaneous Injections With 1 mg/mL, 3 mg/mL, and 10 mg/mL Semaglutide Strengths and the Absolute Bioavailability of Semaglutide</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&#xD;
      pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of&#xD;
      three different strengths of semaglutide and the absolute bioavailability of semaglutide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the semaglutide plasma concentration curve</measure>
    <time_frame>From day 0-day 35/840 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum observed semaglutide plasma concentration</measure>
    <time_frame>From the concentration-time curves 0 - 840 hours following s.c. administration of a single dose 0.5 mg semaglutide at different strengths</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the semaglutide plasma concentration-time curve</measure>
    <time_frame>From the concentration-time curves 0 - 840 hours following i.v. administration of a single dose 0.25 mg semaglutide (1 mg/mL)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>From baseline (Visit 2, Day 1) to follow-up (12-14 weeks after Visit 2)</time_frame>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Diabetes</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL).</description>
    <arm_group_label>s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)</arm_group_label>
    <arm_group_label>s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)</arm_group_label>
    <arm_group_label>s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)</arm_group_label>
    <arm_group_label>s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)</arm_group_label>
    <arm_group_label>s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)</arm_group_label>
    <arm_group_label>s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>semaglutide</intervention_name>
    <description>Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL) or intravenously (i.v.) (1mg/mL).</description>
    <arm_group_label>i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)</arm_group_label>
    <arm_group_label>s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects (based on assessment of medical history, physical&#xD;
             examination and clinical laboratory data at screening, as judged by the investigator)&#xD;
&#xD;
          -  Age between 18 and 55 years (both inclusive) at the time of signing informed consent&#xD;
&#xD;
          -  Body mass index (BMI) between 20 and 30 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 not using an adequate contraceptive method. Women of&#xD;
             child-bearing potential must use an effective method of birth control for the duration&#xD;
             of the trial and for 5 weeks following the last dose of semaglutide. Only highly&#xD;
             effective methods of birth control are accepted (i.e. one that results in less than 1&#xD;
             % per year failure rate when used consistently and correctly such as implants,&#xD;
             injectables, combined oral contraceptives, some intrauterine device) or sexual&#xD;
             abstinence or vasectomised 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 (except&#xD;
             routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks&#xD;
             (or within 5 half-lives of the medicinal product, whichever is longest) prior to the&#xD;
             first dosing of semaglutide&#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 or use of any nicotine products (including nicotine patches, gum etc.) in the&#xD;
             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>
      <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>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>January 23, 2015</last_update_submitted>
  <last_update_submitted_qc>January 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02231684
org study id: NN9535-3687
secondary id: 2013-004566-34
secondary id: U1111-1149-3980
nct id: NCT02231684
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacokinetics (the exposure of the trial drug in the body) of subcutaneous injections of
      three different strengths of semaglutide and the absolute bioavailability of semaglutide.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Area under the semaglutide plasma concentration curve
time frame: From day 0-day 35/840 hours
measure: Maximum observed semaglutide plasma concentration
time frame: From the concentration-time curves 0 - 840 hours following s.c. administration of a single dose 0.5 mg semaglutide at different strengths
measure: Area under the semaglutide plasma concentration-time curve
time frame: From the concentration-time curves 0 - 840 hours following i.v. administration of a single dose 0.25 mg semaglutide (1 mg/mL)
measure: Number of treatment emergent adverse events (TEAEs)
time frame: From baseline (Visit 2, Day 1) to follow-up (12-14 weeks after Visit 2)
arm group label: s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)
arm group type: Experimental
arm group label: s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
arm group type: Experimental
arm group label: s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)
arm group type: Experimental
arm group label: s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)
arm group type: Experimental
arm group label: s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)
arm group type: Experimental
arm group label: s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
arm group type: Experimental
arm group label: i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
arm group type: Experimental
arm group label: s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml)
arm group type: Experimental
intervention type: Drug
intervention name: semaglutide
description: Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL).
arm group label: s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)
arm group label: s.c. 0.5 mg (1 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)
arm group label: s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
arm group label: s.c. 0.5 mg (10 mg/ml) followed by s.c. 0.5 mg (3 mg/ml)
arm group label: s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
arm group label: s.c. 0.5 mg (3 mg/ml) followed by s.c. 0.5 mg (10 mg/ml)
intervention type: Drug
intervention name: semaglutide
description: Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL) or intravenously (i.v.) (1mg/mL).
arm group label: i.v. 0.25 mg (1 mg/ml) followed by s.c. 0.5 mg (1 mg/ml)
arm group label: s.c. 0.5 mg (1 mg/ml) followed by i.v. 0.25 mg (1 mg/ml)
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
responsible party type: Sponsor