<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/NCT01690169</url>
  </required_header>
  <id_info>
    <org_study_id>NN9927-3909</org_study_id>
    <secondary_id>2012-000047-27</secondary_id>
    <secondary_id>U1111-1126-7584</secondary_id>
    <nct_id>NCT01690169</nct_id>
  </id_info>
  <brief_title>Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects</brief_title>
  <official_title>Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male 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 the trial is to investigate safety,&#xD;
      tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single&#xD;
      doses of NNC0113-0987 in healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2012</start_date>
  <completion_date type="Actual">December 11, 2012</completion_date>
  <primary_completion_date type="Actual">December 11, 2012</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of treatment emergent adverse events (TEAEs)</measure>
    <time_frame>From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number and severity of hypoglycaemic episodes</measure>
    <time_frame>From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC, the area under the NNC0113-0987 plasma concentration-time curve</measure>
    <time_frame>From dosing visit to infinity</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax, the maximum plasma concentration of NNC0113-0987</measure>
    <time_frame>From dosing visit until last PK sampling visit (e.g. day 11)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tmax, the time to maximum plasma concentration of NNC0113-0987</measure>
    <time_frame>From dosing visit until last PK sampling visit (e.g. day 11)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Diabetes</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>NNC0113-0987</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NNC0113-0987</intervention_name>
    <description>A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.</description>
    <arm_group_label>NNC0113-0987</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>A single dose of oral placebo administered.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects with good general health as judged by the investigator, based on medical&#xD;
             history, physical examination including 12-lead electrocardiogram (ECG), vital signs,&#xD;
             and blood assessments at the screening visit&#xD;
&#xD;
          -  Body mass index (BMI) above or equal to 18.5 and below 30 kg/m^ 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male subjects who are sexually active and not surgically sterilised, who or whose&#xD;
             partner is unwilling to use two different forms of effective contraception, one of&#xD;
             which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream)&#xD;
             for the duration of the trial and for 12 weeks following the last dose of trial&#xD;
             medication&#xD;
&#xD;
          -  Participation in another trial within 90 days prior to screening&#xD;
&#xD;
          -  Subjects with a history of or presence of cancer, diabetes, or any clinically&#xD;
             significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal&#xD;
             (including gastroesophageal reflux disease and irritable bowel syndrome),&#xD;
             endocrinological, haematological, dermatological, venereal, neurological, or&#xD;
             psychiatric disease or other major disorders that might have an impact on the current&#xD;
             trial, as judged by the investigator&#xD;
&#xD;
          -  Subjects who are known to have hepatitis or who are carriers of the Hepatitis B&#xD;
             surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the&#xD;
             test for Human Immunodeficiency Virus (HIV) antibodies&#xD;
&#xD;
          -  History of acute idiopathic or chronic pancreatitis&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 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>Nottingham</city>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://novonordisk-trials.com</url>
    <description>Clinical Trials at Novo Nordisk</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>February 24, 2017</last_update_submitted>
  <last_update_submitted_qc>February 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_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/NCT01690169
org study id: NN9927-3909
secondary id: 2012-000047-27
secondary id: U1111-1126-7584
nct id: NCT01690169
lead sponsor: 
has dmc: No
This trial is conducted in Europe. The aim of the trial is to investigate safety,
      tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single
      doses of NNC0113-0987 in healthy male subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of treatment emergent adverse events (TEAEs)
time frame: From the dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)
measure: Number and severity of hypoglycaemic episodes
time frame: From dosing visit and until completion of the post-treatment follow-up visit (i.e. day 12-25)
measure: AUC, the area under the NNC0113-0987 plasma concentration-time curve
time frame: From dosing visit to infinity
measure: Cmax, the maximum plasma concentration of NNC0113-0987
time frame: From dosing visit until last PK sampling visit (e.g. day 11)
measure: tmax, the time to maximum plasma concentration of NNC0113-0987
time frame: From dosing visit until last PK sampling visit (e.g. day 11)
arm group label: NNC0113-0987
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: NNC0113-0987
description: A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.
arm group label: NNC0113-0987
intervention type: Drug
intervention name: placebo
description: A single dose of oral placebo administered.
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Global Clinical Registry (GCR,1452)
role: Study Director
affiliation: Novo Nordisk A/S
facility: 
country: United Kingdom
url: http://novonordisk-trials.com
description: Clinical Trials at Novo Nordisk
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2