<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/NCT02217826</url>
  </required_header>
  <id_info>
    <org_study_id>DG3173-I-003</org_study_id>
    <nct_id>NCT02217826</nct_id>
  </id_info>
  <brief_title>Single Dose Pharmacodynamic and Pharmacokinetic Study of DG3173</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aspireo Pharmaceuticals Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aspireo Pharmaceuticals Limited</source>
  <brief_summary>
    <textblock>
      In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with&#xD;
      the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and&#xD;
      placebo control. The main purpose of the study was to investigate the effects of each&#xD;
      treatment on the control of plasma glucose as well as the secretion of insulin and glucagon&#xD;
      following a standard meal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <primary_completion_date type="Actual">April 2014</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of glucose, insulin and glucagon in plasma.</measure>
    <time_frame>Before and 0.5h, 0.75h, 1h, 1.25 h, 1.5h, 1.75h, 2.25h, 2.75, 3.25h, 3.75h and 4.25h after drug adaministration until 4.25 hours after administration</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>DG3173</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Octreotide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DG3173</intervention_name>
    <arm_group_label>DG3173</arm_group_label>
    <arm_group_label>Octreotide</arm_group_label>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <arm_group_label>DG3173</arm_group_label>
    <arm_group_label>Octreotide</arm_group_label>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octreotide</intervention_name>
    <arm_group_label>DG3173</arm_group_label>
    <arm_group_label>Octreotide</arm_group_label>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ethnic origin: Caucasian&#xD;
&#xD;
          -  Body Mass Index (BMI): 19-27 kg/m2 inclusive&#xD;
&#xD;
          -  Medical history without clinically relevant pathologies&#xD;
&#xD;
          -  Physical examination parameters without signs of clinically relevant pathologies&#xD;
&#xD;
          -  Electrocardiogram recording without signs of clinically relevant pathology, in&#xD;
             particular QTc (Bazett) &lt;450 ms&#xD;
&#xD;
          -  Values for hematology and for biochemistry tests of blood and urine within the normal&#xD;
             range or showing no clinically relevant deviation as judged by the Investigator (in&#xD;
             particular for alanine transaminase, aspartate transaminase, lactate dehydrogenase,&#xD;
             gamma glutamyl transferase, alkaline phosphatase, bilirubin, and α-amylase)&#xD;
&#xD;
          -  Subjects with partner of child bearing potential must be willing to practice a&#xD;
             medically approved method of contraception (e.g., condom in combination with hormonal&#xD;
             contraception or intrauterine device or a diaphragm with spermicide after the first&#xD;
             drug administration and for one month after participation in the study or are&#xD;
             vasectomized since &gt; 6 months or has a partner being sterilized since &gt; 6 months&#xD;
&#xD;
          -  Having given written informed consent before any study-related activities are carried&#xD;
             out&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of clinically relevant pathology or disease&#xD;
&#xD;
          -  Any history of moderate or severe hypertension, hypotension or orthostatic hypotension&#xD;
&#xD;
          -  Mental handicap&#xD;
&#xD;
          -  Legal incapacity&#xD;
&#xD;
          -  Any history of clinically important emotional and/or psychiatric illness or of any&#xD;
             clinically important neurological disorders and/or epilepsy&#xD;
&#xD;
          -  Chronic diarrhea or other acute or chronic gastrointestinal disorders&#xD;
&#xD;
          -  Presence or history of endocrine disorders&#xD;
&#xD;
          -  Presence or history of gallstone disease&#xD;
&#xD;
          -  Known hypersensitivity to the study drug or constituent of the study drug&#xD;
&#xD;
          -  History of any relevant allergy, especially drug and/or food allergies&#xD;
&#xD;
          -  Strict vegetarian&#xD;
&#xD;
          -  Regular treatment with medications during three months prior to randomization&#xD;
&#xD;
          -  Receipt of any prescription or non-prescription medication, including multi vitamin&#xD;
             preparations within 14 days prior randomization and for the duration of the study&#xD;
&#xD;
          -  Use of St. John's Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours&#xD;
             prior to randomization&#xD;
&#xD;
          -  Participation in a clinical study within 30 days prior to randomization&#xD;
&#xD;
          -  Donation of blood (450 ml) within 60 days prior to randomization&#xD;
&#xD;
          -  Receipt of blood, blood products or plasma derivates one year prior to randomization&#xD;
&#xD;
          -  Regular smoking of &gt;5 cigarettes per day within the past three months&#xD;
&#xD;
          -  Any history of alcohol abuse or drug addiction&#xD;
&#xD;
          -  Known consumer of drugs of abuse&#xD;
&#xD;
          -  Known to be infected with HBsAg, anti-HCV, or anti-HIV1 and HIV2&#xD;
&#xD;
          -  Consumption of abnormal quantities of coffee or tea (i.e., more than 5 cups per day [1&#xD;
             cup = 150 ml])&#xD;
&#xD;
          -  Any disease which in the Investigator's opinion would exclude the subject from the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 18, 2014</last_update_submitted>
  <last_update_submitted_qc>August 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</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>Octreotide</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/NCT02217826
org study id: DG3173-I-003
nct id: NCT02217826
lead sponsor: 
In this single-dose, randomized, 5-way cross-over study, healthy volunteers were treated with
      the highest approved dose of octreotide, three different doses of Somatoprim (DG3173) and
      placebo control. The main purpose of the study was to investigate the effects of each
      treatment on the control of plasma glucose as well as the secretion of insulin and glucagon
      following a standard meal.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Concentration of glucose, insulin and glucagon in plasma.
time frame: Before and 0.5h, 0.75h, 1h, 1.25 h, 1.5h, 1.75h, 2.25h, 2.75, 3.25h, 3.75h and 4.25h after drug adaministration until 4.25 hours after administration
arm group label: DG3173
arm group type: Experimental
arm group label: Saline
arm group type: Placebo Comparator
arm group label: Octreotide
arm group type: Active Comparator
intervention type: Drug
intervention name: DG3173
arm group label: DG3173
arm group label: Octreotide
arm group label: Saline
intervention type: Drug
intervention name: Saline
arm group label: DG3173
arm group label: Octreotide
arm group label: Saline
intervention type: Drug
intervention name: Octreotide
arm group label: DG3173
arm group label: Octreotide
arm group label: Saline
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Octreotide