<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/NCT02217839</url>
  </required_header>
  <id_info>
    <org_study_id>DG3173-I-002</org_study_id>
    <nct_id>NCT02217839</nct_id>
  </id_info>
  <brief_title>Multiple Ascending Dose Tolerability, Pharmacokinetic and Pharmacodynamic 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>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This multi-ascending dose study is designed to investigate the safety, tolerability,&#xD;
      pharmacokinetic and side effect profile of multiple ascending doses of DG3173, in up to 48&#xD;
      healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <primary_completion_date type="Actual">January 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of serious adverse events or withdrawals due to adverse events. Laboratory investigations (including biochemistry, hematology, and urinalysis), vital signs (blood pressure, pulse rate), and 12-lead ECG.</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</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>DG3173+Octreotide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DG3173</intervention_name>
    <arm_group_label>DG3173</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DG3173+Octreotide</intervention_name>
    <arm_group_label>DG3173+Octreotide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octreotide</intervention_name>
    <arm_group_label>DG3173</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DG3173 Placebo</intervention_name>
    <arm_group_label>DG3173</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DG3173 Placebo+Octreotide Placebo</intervention_name>
    <arm_group_label>DG3173+Octreotide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Octreotide+DG3173 Placebo</intervention_name>
    <arm_group_label>DG3173+Octreotide</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 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;
      </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 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 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/NCT02217839
org study id: DG3173-I-002
nct id: NCT02217839
lead sponsor: 
has dmc: No
This multi-ascending dose study is designed to investigate the safety, tolerability,
      pharmacokinetic and side effect profile of multiple ascending doses of DG3173, in up to 48
      healthy volunteers.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Number of serious adverse events or withdrawals due to adverse events. Laboratory investigations (including biochemistry, hematology, and urinalysis), vital signs (blood pressure, pulse rate), and 12-lead ECG.
time frame: 10 days
arm group label: DG3173
arm group type: Experimental
arm group label: DG3173+Octreotide
arm group type: Experimental
intervention type: Drug
intervention name: DG3173
arm group label: DG3173
intervention type: Drug
intervention name: DG3173+Octreotide
arm group label: DG3173+Octreotide
intervention type: Drug
intervention name: Octreotide
arm group label: DG3173
intervention type: Drug
intervention name: DG3173 Placebo
arm group label: DG3173
intervention type: Drug
intervention name: DG3173 Placebo+Octreotide Placebo
arm group label: DG3173+Octreotide
intervention type: Drug
intervention name: Octreotide+DG3173 Placebo
arm group label: DG3173+Octreotide
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Octreotide