<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/NCT03279302</url>
  </required_header>
  <id_info>
    <org_study_id>ZP1848-16182</org_study_id>
    <nct_id>NCT03279302</nct_id>
  </id_info>
  <brief_title>Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Open-Label, Partially Randomized, 3-Part, Parallel Group Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide (ZP1848) After a Single Intravenous Injection and After Multiple Subcutaneous Injections in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of&#xD;
      glepaglutide and its primary active metabolites following once-daily and once-weekly&#xD;
      subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy&#xD;
      subjects.&#xD;
&#xD;
      Glepaglutide is a proposed International Nonproprietary Name for ZP1848&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">December 18, 2017</completion_date>
  <primary_completion_date type="Actual">December 18, 2017</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>Pharmacokinetic parameter - half life</measure>
    <time_frame>Day 0 up to Day 73</time_frame>
    <description>Half life of glepaglutide and active metabolites</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter - total body clearance</measure>
    <time_frame>Day 0 to Day 22</time_frame>
    <description>Total body clearance after IV administration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter - Apparent clearance</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>CL/F for subcutaneous doses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter - Volume of distribution</measure>
    <time_frame>Day 0- Day 22</time_frame>
    <description>Volume of distribution after IV dosing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameter - apparent volume of distribution</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>Vss/F and Vz/F for subcutaneous doses</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter - Cmax</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>Maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter - tmax</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>time of maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameter - AUC</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>Area under the curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamic parameter - plasma citrulline levels</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>change in plasma citrulline levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ADA incidence</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>Overall incidence of anti-glepaglutide antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability - AEs</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability - ECGs</measure>
    <time_frame>Day 0 to Day 73</time_frame>
    <description>12 lead electrocardiogram parameters</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glepaglutide</intervention_name>
    <description>Solution for injection</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_label>Group E</arm_group_label>
    <other_name>ZP1848</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In good health, determined by no clinically significant findings from medical history,&#xD;
             physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory&#xD;
             evaluations&#xD;
&#xD;
          -  Body Mass index between 18 and 30.0 kg/m2&#xD;
&#xD;
          -  Able to comply with all the trial procedures&#xD;
&#xD;
          -  females will not be pregnant or lactating&#xD;
&#xD;
          -  If female of childbearing potential or male agree to use contraception as defined in&#xD;
             the protocol&#xD;
&#xD;
          -  Male subjects must also be willing to refrain from donating sperm from trial Check-in&#xD;
             until 90 days after the last dose&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant history or clinical manifestation of any metabolic, allergic,&#xD;
             dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,&#xD;
             gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder&#xD;
&#xD;
          -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food, or other substance&#xD;
&#xD;
          -  History of bowel obstruction, stomach or intestinal surgery or resection that would&#xD;
             potentially alter absorption and/or excretion of orally administered drugs&#xD;
             (uncomplicated appendectomy and/or cholecystectomy or hernia repair will be allowed).&#xD;
&#xD;
          -  Clinically significant abnormality on 12-lead ECG&#xD;
&#xD;
          -  Clinically significant abnormality in hematology, clinical chemistry, or urinalysis&#xD;
&#xD;
          -  History of alcoholism or drug/chemical abuse within 2 years&#xD;
&#xD;
          -  Alcohol consumption of &gt; 21 units per week for males and &gt; 14 units for females&#xD;
&#xD;
          -  Positive urine drug screen&#xD;
&#xD;
          -  Positive hepatitis panel and/or positive human immunodeficiency test&#xD;
&#xD;
          -  Receipt of any investigational product within 30 days or 5 half-lives&#xD;
&#xD;
          -  Previous exposure to GLP-1, GLP-2, human growth hormone, or analogs thereof 30 days&#xD;
             prior to Check-in&#xD;
&#xD;
          -  Use or intend to use any medications/products known to be strong inhibitors or strong&#xD;
             inducers of cytochrome P450 3A enzyme, including St. John's wort&#xD;
&#xD;
          -  Use of tobacco, smoking cessation products, or products containing nicotine (including&#xD;
             but not limited to cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine&#xD;
             lozenges, or nicotine gum ) within 3 months prior to Screening&#xD;
&#xD;
          -  Receipt of blood products within 2 months prior to Check-in and throughout the trial.&#xD;
&#xD;
          -  Donation of blood or significant blood loss from 56 days prior to Screening, plasma&#xD;
             from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening and&#xD;
             throughout the trial.&#xD;
&#xD;
          -  Poor peripheral venous access.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Covance CRU</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>December 21, 2017</last_update_submitted>
  <last_update_submitted_qc>December 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2017</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/NCT03279302
org study id: ZP1848-16182
nct id: NCT03279302
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of
      glepaglutide and its primary active metabolites following once-daily and once-weekly
      subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy
      subjects.

      Glepaglutide is a proposed International Nonproprietary Name for ZP1848
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetic parameter - half life
time frame: Day 0 up to Day 73
description: Half life of glepaglutide and active metabolites
measure: Pharmacokinetic parameter - total body clearance
time frame: Day 0 to Day 22
description: Total body clearance after IV administration
measure: Pharmacokinetic parameter - Apparent clearance
time frame: Day 0 to Day 73
description: CL/F for subcutaneous doses
measure: Pharmacokinetic parameter - Volume of distribution
time frame: Day 0- Day 22
description: Volume of distribution after IV dosing
measure: Pharmacokinetic parameter - apparent volume of distribution
time frame: Day 0 to Day 73
description: Vss/F and Vz/F for subcutaneous doses
measure: Pharmacokinetic parameter - Cmax
time frame: Day 0 to Day 73
description: Maximum observed plasma concentration
measure: Pharmacokinetic parameter - tmax
time frame: Day 0 to Day 73
description: time of maximum observed plasma concentration
measure: Pharmacokinetic parameter - AUC
time frame: Day 0 to Day 73
description: Area under the curve
measure: Pharmacodynamic parameter - plasma citrulline levels
time frame: Day 0 to Day 73
description: change in plasma citrulline levels
measure: ADA incidence
time frame: Day 0 to Day 73
description: Overall incidence of anti-glepaglutide antibodies
measure: Safety and tolerability - AEs
time frame: Day 0 to Day 73
description: Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions
measure: Safety and tolerability - ECGs
time frame: Day 0 to Day 73
description: 12 lead electrocardiogram parameters
arm group label: Group A
arm group type: Experimental
description: 1 mg glepaglutide once daily, given as single SC injections on Days 1 to 7
arm group label: Group B
arm group type: Experimental
description: 5 mg glepaglutide once daily, given as single SC injections on Days 1 to 7
arm group label: Group C
arm group type: Experimental
description: 5 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36
arm group label: Group D
arm group type: Experimental
description: 10 mg glepaglutide once weekly, given as single SC injections on Days 1, 8, 15, 22, 29, and 36
arm group label: Group E
arm group type: Experimental
description: 1 mg glepaglutide, given as an IV infusion at a rate of 4 mg/h for 15 minutes on Day 1
intervention type: Drug
intervention name: Glepaglutide
description: Solution for injection
arm group label: Group A
arm group label: Group B
arm group label: Group C
arm group label: Group D
arm group label: Group E
other name: ZP1848
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor