xml: <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/NCT05995704</url>
    </required_header>
    <id_info>
      <org_study_id>TA799-020</org_study_id>
      <nct_id>NCT05995704</nct_id>
    </id_info>
    <brief_title>Evaluation of Apraglutide on Gastric Emptying</brief_title>
    <official_title>A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Center, Multiple-Dose, Parallel Trial Evaluating the Impact of Apraglutide on Gastric Emptying of Liquids in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VectivBio AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VectivBio AG</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary objective is to assess the effect of apraglutide on gastric emptying of liquids&#xD;
        in healthy subjects, as measured by the PK of acetaminophen mixed with a liquid meal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, double-blind, randomized, multiple-dose, parallel trial with a total&#xD;
        duration of up to 50 days. The trial population will consist of healthy volunteers. Eligible&#xD;
        subjects will be randomized to receive either subcutaneous (SC) apraglutide or matching&#xD;
        placebo. The effect of apraglutide on gastric emptying of liquids will be assessed by the&#xD;
        measure of PK of acetaminophen mixed with a liquid meal.&#xD;
  &#xD;
        There will be two treatment periods, occurring according to the same sequence. In Period 1&#xD;
        acetaminophen will be given on Day 1, apraglutide/placebo will be injected on Day2. In Period&#xD;
        2 apraglutide/placebo will be injected on Day 9 and acetaminophen will be given on Day 10.&#xD;
        This will allow to assess the PK of acetaminophen without the effect of apraglutide in Period&#xD;
        1, and to assess the PK of acetaminophen at the maximum concentration of apraglutide in&#xD;
        Period 2.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 2, 2023</start_date>
    <completion_date type="Actual">July 24, 2023</completion_date>
    <primary_completion_date type="Actual">July 24, 2023</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>Other</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>The pharmacist and designated staff will be unblinded.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum plasma concentration (Cmax) of acetaminophen</measure>
      <time_frame>0-300 Minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Time at which the maximum plasma concentration is observed (tmax) of acetaminophen</measure>
      <time_frame>0-300 Minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)</measure>
      <time_frame>0-14 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the acetaminophen concentration-time curve: AUC0-300min</measure>
      <time_frame>0-300 Minutes</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area under the acetaminophen concentration-time curve: AUC0-60min</measure>
      <time_frame>0-60 Minutes</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Height</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>In cm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>In kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical examination</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>Clinically significant outcome (as normal or abnormal) for physical examination of eyes, neurological, gastrointestinal, respiratory, circulatory, muscular, cardiovascular, lymphatic, ears, nose, throat.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence, nature and severity of adverse events (AEs) with apraglutide</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical chemistry</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>Clinical Chemistry panel of analytes will be examined for clinically significant changes.&#xD;
  Clinical chemistry analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hematology</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>Hematology panel of analytes will be examined for clinically significant changes.&#xD;
  Hematology analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemostasis</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>Hemostasis INR will be examined for clinically significant changes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-drug antibodies (ADA) analysis</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>ADA will be will be examined for clinically significant changes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urine analysis</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>Urine analysis panel of analytes will be examined for clinically significant changes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in vital signs</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>Systolic and diastolic blood pressure in mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in vital signs</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>Pulse rate in Beats per Minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in body temperature in °C</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in electrocardiogram</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>ECG QT Interval</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in electrocardiogram</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>ECG PR interval</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in electrocardiogram</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>ECG QRS interval</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of clinically relevant changes in electrocardiogram</measure>
      <time_frame>Through study completion, up to 24 days</time_frame>
      <description>ECG rhythm</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">36</enrollment>
    <condition>Healthy Subjects</condition>
    <arm_group>
      <arm_group_label>Apraglutide SC injections</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>Apraglutide</intervention_name>
      <description>Peptide analogue of GLP-2</description>
      <arm_group_label>Apraglutide SC injections</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching placebo to apraglutide</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Acetaminophen</intervention_name>
      <description>Acetaminophen mixed with a liquid meal</description>
      <arm_group_label>Apraglutide SC injections</arm_group_label>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age between 18 and 45 years inclusive&#xD;
  &#xD;
            -  Subjects who are willing and able to comply with the study procedures&#xD;
  &#xD;
            -  Subjects able to understand and willing to sign the informed consent&#xD;
  &#xD;
            -  Body mass index (BMI) of ≥18.0 to ≤30.0 kg/m2; and a total body weight of &gt;50 kg (110&#xD;
               lb).&#xD;
  &#xD;
            -  Women of childbearing potential (WOCBP) having undergone bilateral tubal occlusion or&#xD;
               with vasectomized partner. Sterilized or infertile or postmenopausal females.&#xD;
  &#xD;
            -  Male subjects with a WOCBP partner using highly effective methods of contraception and&#xD;
               agreeing on no sperm donation during the trial and for 2 weeks after (EOT) visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of clinically significant GI, bronchopulmonary, neurological, cardiovascular,&#xD;
               endocrine, or allergic disease&#xD;
  &#xD;
            -  Known hypersensitivity to the investigational medicinal product (IMP), any of their&#xD;
               excipients or drugs of the same class&#xD;
  &#xD;
            -  If capable of reproduction, unwilling to use an effective form of contraception&#xD;
  &#xD;
            -  If a WOCBP, a positive urine/blood pregnancy test&#xD;
  &#xD;
            -  Breast-feeding women&#xD;
  &#xD;
            -  Positive urine/blood test for alcohol and drugs of abuse&#xD;
  &#xD;
            -  Use of prohibited medications or herbal remedies&#xD;
  &#xD;
            -  Known presence or history of intestinal polyps&#xD;
  &#xD;
            -  Known presence or history of any type of cancer&#xD;
  &#xD;
            -  Pancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas&#xD;
               infection, and increased blood amylase and lipase (&gt;2.0-5.0×upper limit of normal&#xD;
               range)&#xD;
  &#xD;
            -  Participation in an investigational drug or device study within 30 days prior to&#xD;
               Screening&#xD;
  &#xD;
            -  Donation of blood over 500 mL within 2 months prior to Screening&#xD;
  &#xD;
            -  Use of tobacco products (i.e., smokes more than 5 cigarettes per day or equivalent)&#xD;
  &#xD;
            -  Concomitant disease or condition that could interfere with, or for which the treatment&#xD;
               of might interfere with, the conduct of the study, or that would, in the opinion of&#xD;
               the Investigator, pose an unacceptable risk to the subject in this trial&#xD;
  &#xD;
            -  Any intercurrent clinically significant illness in the previous 28 days before Day 1&#xD;
               of this study&#xD;
  &#xD;
            -  Positive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo,&#xD;
               hepatitis A (HAV IGM), hepatitis B surface antigen (HBsAgB), or hepatitis C virus&#xD;
               (HCV)&#xD;
  &#xD;
            -  Unwillingness or inability to comply with the study protocol for any other reason&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bolognani</last_name>
      <role>Study Director</role>
      <affiliation>VectivBio AG</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>ICON Clinical Research Unit</name>
        <address>
          <city>Groningen</city>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gastric emptying</keyword>
    <keyword>Pharmacokinetics of acetaminophen</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetaminophen</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995704
  org study id: TA799-020
  nct id: NCT05995704
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The primary objective is to assess the effect of apraglutide on gastric emptying of liquids
        in healthy subjects, as measured by the PK of acetaminophen mixed with a liquid meal.
  This is a single-center, double-blind, randomized, multiple-dose, parallel trial with a total
        duration of up to 50 days. The trial population will consist of healthy volunteers. Eligible
        subjects will be randomized to receive either subcutaneous (SC) apraglutide or matching
        placebo. The effect of apraglutide on gastric emptying of liquids will be assessed by the
        measure of PK of acetaminophen mixed with a liquid meal.
  
        There will be two treatment periods, occurring according to the same sequence. In Period 1
        acetaminophen will be given on Day 1, apraglutide/placebo will be injected on Day2. In Period
        2 apraglutide/placebo will be injected on Day 9 and acetaminophen will be given on Day 10.
        This will allow to assess the PK of acetaminophen without the effect of apraglutide in Period
        1, and to assess the PK of acetaminophen at the maximum concentration of apraglutide in
        Period 2.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: The pharmacist and designated staff will be unblinded.
  measure: Maximum plasma concentration (Cmax) of acetaminophen
  time frame: 0-300 Minutes
  measure: Time at which the maximum plasma concentration is observed (tmax) of acetaminophen
  time frame: 0-300 Minutes
  measure: Area under the acetaminophen concentration-time curve: AUCinf (AUClast in case AUCinf cannot be estimated)
  time frame: 0-14 hours
  measure: Area under the acetaminophen concentration-time curve: AUC0-300min
  time frame: 0-300 Minutes
  measure: Area under the acetaminophen concentration-time curve: AUC0-60min
  time frame: 0-60 Minutes
  measure: Height
  time frame: Through study completion, up to 24 days
  description: In cm
  measure: Weight
  time frame: Through study completion, up to 24 days
  description: In kg
  measure: Physical examination
  time frame: Through study completion, up to 24 days
  description: Clinically significant outcome (as normal or abnormal) for physical examination of eyes, neurological, gastrointestinal, respiratory, circulatory, muscular, cardiovascular, lymphatic, ears, nose, throat.
  measure: The incidence, nature and severity of adverse events (AEs) with apraglutide
  time frame: Through study completion, up to 24 days
  measure: Clinical chemistry
  time frame: Through study completion, up to 24 days
  description: Clinical Chemistry panel of analytes will be examined for clinically significant changes.
  Clinical chemistry analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
  measure: Hematology
  time frame: Through study completion, up to 24 days
  description: Hematology panel of analytes will be examined for clinically significant changes.
  Hematology analytes will be listed by subject. Descriptive statistics will be used to assess any changes in clinical laboratory results during and following trial treatment administration. Values outside the reference ranges will be highlighted and clinical significance stated.
  measure: Hemostasis
  time frame: Through study completion, up to 24 days
  description: Hemostasis INR will be examined for clinically significant changes
  measure: Anti-drug antibodies (ADA) analysis
  time frame: Through study completion, up to 24 days
  description: ADA will be will be examined for clinically significant changes
  measure: Urine analysis
  time frame: Through study completion, up to 24 days
  description: Urine analysis panel of analytes will be examined for clinically significant changes
  measure: Occurrence of clinically relevant changes in vital signs
  time frame: Through study completion, up to 24 days
  description: Systolic and diastolic blood pressure in mmHg
  measure: Occurrence of clinically relevant changes in vital signs
  time frame: Through study completion, up to 24 days
  description: Pulse rate in Beats per Minute
  measure: Changes in body temperature in °C
  time frame: Through study completion, up to 24 days
  measure: Occurrence of clinically relevant changes in electrocardiogram
  time frame: Through study completion, up to 24 days
  description: ECG QT Interval
  measure: Occurrence of clinically relevant changes in electrocardiogram
  time frame: Through study completion, up to 24 days
  description: ECG PR interval
  measure: Occurrence of clinically relevant changes in electrocardiogram
  time frame: Through study completion, up to 24 days
  description: ECG QRS interval
  measure: Occurrence of clinically relevant changes in electrocardiogram
  time frame: Through study completion, up to 24 days
  description: ECG rhythm
  arm group label: Apraglutide SC injections
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Apraglutide
  description: Peptide analogue of GLP-2
  arm group label: Apraglutide SC injections
  intervention type: Drug
  intervention name: Placebo
  description: Matching placebo to apraglutide
  arm group label: Placebo
  intervention type: Drug
  intervention name: Acetaminophen
  description: Acetaminophen mixed with a liquid meal
  arm group label: Apraglutide SC injections
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bolognani
  role: Study Director
  affiliation: VectivBio AG
  facility: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Acetaminophen