<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/NCT04465396</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-633-1001</org_study_id>
    <nct_id>NCT04465396</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Participants</brief_title>
  <official_title>A Randomized, Open-label, Two-treatment, Two-period, Single-dose, Crossover Study to Evaluate the Bioavailability of Teduglutide Administered Subcutaneously by Syringe Injection Versus Pen Injector in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Takeda Development Center Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the bioavailability of teduglutide administered as a&#xD;
      single subcutaneous (SC) fixed dose (depending upon participant weightband assignment)&#xD;
      delivered by a syringe injection and the same fixed dose delivered by the pen injector in&#xD;
      healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 2-period crossover study and consists of two cohorts. Cohort 1 consists of&#xD;
      participant's with greater than or equal to (&gt;=) 40.0 kilogram (kg) to lesser than or equal&#xD;
      to (&lt;=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (&gt;) 75.0&#xD;
      kg to &lt;= 120.0 kg of weight. Participants in each cohort will be randomized to 1 of 2&#xD;
      treatment sequences AB or BA. Randomization will be stratified by injection site (i.e.,&#xD;
      thigh, abdomen, and arm) within each cohort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2021</start_date>
  <completion_date type="Actual">August 20, 2021</completion_date>
  <primary_completion_date type="Actual">August 20, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Teduglutide</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
    <description>Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide by Injection Site</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
    <description>AUC0-last of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
    <description>Cmax of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
    <description>AUC0-infinity of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Body Clearance (CL/F) of Teduglutide</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
    <description>CL/F for extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vz/F) of Teduglutide</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
    <description>Vz/F associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. Number of participants with TEAEs included injection site reactions and injection site injury assessments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change in Vital Signs</measure>
    <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
    <description>Vital signs included body temperature, respiratory rate, blood pressure, and heart rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments</measure>
    <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
    <description>Clinical laboratory assessments included hematology, serum chemistry, coagulation, and urinalysis. Changes in laboratory values may be considered as AE if they were judged to be clinically significant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes in Physical Examinations</measure>
    <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
    <description>Physical examination included examination of respiratory, cardiovascular, and gastrointestinal system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Device Malfunction</measure>
    <time_frame>Day 1</time_frame>
    <description>Number of participants with device malfunction was assessed and reported. The site staff reported any malfunctions whilst using the device.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teduglutide, 3 mg, subcutaneous (SC) injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A1), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B1). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B1), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A1). A Washout Period of 7 days was maintained between the Treatment Periods 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A2), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B2), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Teduglutide</intervention_name>
    <description>Participants received 3 mg or 4 mg of Teduglutide SC syringe injection followed by pen injector or vice versa depending upon the treatment sequence AB or BA on Day 1 of Treatment Periods 1 and 2.</description>
    <arm_group_label>Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)</arm_group_label>
    <arm_group_label>Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)</arm_group_label>
    <arm_group_label>Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)</arm_group_label>
    <arm_group_label>Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)</arm_group_label>
    <other_name>TAK-633</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Syringe Injection</intervention_name>
    <description>Teduglutide was administered using syringe.</description>
    <arm_group_label>Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)</arm_group_label>
    <arm_group_label>Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)</arm_group_label>
    <arm_group_label>Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)</arm_group_label>
    <arm_group_label>Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pen injector</intervention_name>
    <description>Teduglutide was administered using pen injector.</description>
    <arm_group_label>Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)</arm_group_label>
    <arm_group_label>Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)</arm_group_label>
    <arm_group_label>Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)</arm_group_label>
    <arm_group_label>Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An understanding, ability, and willingness to fully comply with study procedures and&#xD;
             restrictions.&#xD;
&#xD;
          -  Ability to voluntarily provide written, signed, and dated informed consent and assent&#xD;
             as applicable to participate in the study.&#xD;
&#xD;
          -  Aged 18 - 45 inclusive at the time of consent. The date of signature of the informed&#xD;
             consent is defined as the beginning of the screening period. This inclusion criterion&#xD;
             will only be assessed at the first screening visit.&#xD;
&#xD;
          -  Male, or non-pregnant, non-lactating female who agrees to comply with any applicable&#xD;
             contraceptive requirements of the protocol or females of non-childbearing potential.&#xD;
&#xD;
          -  Considered &quot;healthy&quot; by the investigator. Healthy status is defined by absence of&#xD;
             evidence of any active or chronic disease following a detailed medical and surgical&#xD;
             history, a full physical examination including vital signs, 12-lead electrocardiogram&#xD;
             (ECG), hematology, coagulation (as appropriate), serum chemistry, and urinalysis.&#xD;
&#xD;
          -  Body mass index (BMI) &gt;= 18.0 and l&lt;=32.0 kilogram per square meter (kg/m^2) at&#xD;
             screening. Body weight for a participant in Cohort 1 will be &gt;= 40.0 kg to &lt;= 75.0 kg,&#xD;
             and body weight for a participant in Cohort 2 will be &gt; 75.0 kg to &lt;= 120.0 kg,&#xD;
             inclusive. This inclusion criterion will be assessed at the screening visit and&#xD;
             confirmed at first check-in.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any hematological, hepatic, respiratory, cardiovascular, renal,&#xD;
             neurological or psychiatric disease, gall bladder removal, or current or recurrent&#xD;
             disease that could affect the action, absorption, or disposition of the&#xD;
             investigational product, or clinical or laboratory assessments.&#xD;
&#xD;
          -  Current or relevant history of physical or psychiatric illness, any medical disorder&#xD;
             that may require treatment or make the participant unlikely to fully complete the&#xD;
             study, or any condition that presents undue risk from the investigational product or&#xD;
             procedures.&#xD;
&#xD;
          -  Positive PCR (polymerase chain reaction) test for severe acute respiratory syndrome&#xD;
             coronavirus-2 (SARS-CoV-2), either with the absence or presence of the clinical&#xD;
             symptoms of Coronavirus disease 2019 (COVID-19).&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to teduglutide, closely-related&#xD;
             compounds, or any of the stated ingredients.&#xD;
&#xD;
          -  Significant illness, as judged by the investigator, within 2 weeks of the first dose&#xD;
             of teduglutide.&#xD;
&#xD;
          -  Known history of alcohol or other substance abuse within the last year prior to&#xD;
             screening.&#xD;
&#xD;
          -  Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to&#xD;
             receiving the first dose of teduglutide.&#xD;
&#xD;
          -  Pregnant or lactating female.&#xD;
&#xD;
          -  Within 30 days prior to the first dose of teduglutide:&#xD;
&#xD;
               1. Have used an investigational product (if elimination half-life is lesser than [&lt;]&#xD;
                  6 days, otherwise 5 half-lives)&#xD;
&#xD;
               2. Have been enrolled in a clinical study (including vaccine studies) that, in the&#xD;
                  investigator's (or designee's) opinion, may impact this study&#xD;
&#xD;
               3. Have had any substantial changes in eating habits, as assessed by the&#xD;
                  investigator (or designee)&#xD;
&#xD;
          -  Use of dipeptidyl peptidase 4 inhibitors within 30 days or 5 half-lives, whichever is&#xD;
             greater, prior to administration of the first dose of teduglutide.&#xD;
&#xD;
          -  Confirmed systolic blood pressure &gt; 140 millimeter of mercury (mmHg) or &lt; 90 mmHg, and&#xD;
             diastolic blood pressure &gt; 90 mmHg or &lt; 40 mmHg at screening.&#xD;
&#xD;
          -  Twelve-lead electrocardiogram (ECG) demonstrating QTcF &gt; 450 milliseconds (msec) at&#xD;
             screening. If the QTcF exceeds the aforementioned limits, the ECG should be repeated 2&#xD;
             more times and the average of the 3 QTcF values should be used to determine the&#xD;
             participants eligibility.&#xD;
&#xD;
          -  Positive screen for drugs of abuse or alcohol at screening and at each check-in.&#xD;
&#xD;
          -  Male participants who consume more than 21 units of alcohol per week or regularly&#xD;
             consume more than 3 units per day. Female participants who consume more than 14 units&#xD;
             of alcohol per week or regularly consume more than 2 units per day. (1 alcohol&#xD;
             unit=150 milliliter [mL] of wine, or 360 mL of beer, or 45 mL of 45 percent [%]&#xD;
             alcohol).&#xD;
&#xD;
          -  Positive Human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or&#xD;
             Hepatitis C virus (HCV) antibody screen at screening.&#xD;
&#xD;
          -  Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing&#xD;
             products in any form (e.g. gum, patch) based on participant self-reporting. Ex-users&#xD;
             must report that they have stopped using tobacco for at least 3 months prior to&#xD;
             receiving the first dose of teduglutide.&#xD;
&#xD;
          -  Routine consumption of more than 2 units of caffeine per day or participants who&#xD;
             experience caffeine withdrawal headaches. One caffeine unit is contained in the&#xD;
             following items: one 6 ounce (oz) (180 mL) cup of coffee, two 12 oz (360 mL) cans of&#xD;
             cola, one 12 oz (360 mL) cup of tea, three 1 oz (85 gram [g]) chocolate bars.&#xD;
&#xD;
          -  Prior screen failure, randomization, participation, or enrollment in this study, or&#xD;
             prior exposure to any Glucagon-like peptide 2 (GLP-2) analogs.&#xD;
&#xD;
          -  Presence of lesions, rashes, tattoos, and moles etc. on administration sites not&#xD;
             allowing adequate conduct of injection site reaction and injection site injury&#xD;
             assessment&#xD;
&#xD;
          -  Current use of any medication (including over-the-counter, herbal, or homeopathic&#xD;
             preparations; with the exception of occasional use of ibuprofen [1.2 g per 24 hour&#xD;
             period] or acetaminophen [2 g per 24 hour period]). Current use is defined as use&#xD;
             within 14 days of the first dose of teduglutide and throughout the study.&#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>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b600d4db2bf003ab48ce5</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <results_first_submitted>March 29, 2022</results_first_submitted>
  <results_first_submitted_qc>March 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 4, 2022</results_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Teduglutide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04465396/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT04465396/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 1 investigative site in the United States from 13 January 2021 to 20 August 2021.</recruitment_details>
      <pre_assignment_details>Healthy participants were enrolled in 1 of the 2 cohorts of this 2-period cross-over study to receive teduglutide (TAK-633) 3 or 4 milligrams (mg), subcutaneously by syringe injection (Treatment A1 for Cohort 1 and Treatment A2 for Cohort 2) or through pen injector (Treatment B1 for Cohort 1 and Treatment B2 for Cohort 2). Randomization was stratified by injection site (thigh, abdomen, and arm) within each cohort .</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)</title>
          <description>Teduglutide, 3 mg, subcutaneous (SC) injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A1), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B1). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)</title>
          <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B1), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A1). A Washout Period of 7 days was maintained between the Treatment Periods 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)</title>
          <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A2), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)</title>
          <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B2), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1 (Day 1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period (7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 2 (Day 1)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Set included all participants who received at least one dose of the study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)</title>
          <description>Teduglutide, 3 mg, subcutaneous (SC) injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A1), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B1). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)</title>
          <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B1), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A1). A Washout Period of 7 days was maintained between the Treatment Periods 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)</title>
          <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A2), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)</title>
          <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B2), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="16"/>
            <count group_id="B5" value="64"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.8" lower_limit="20" upper_limit="41"/>
                    <measurement group_id="B2" value="32.4" lower_limit="20" upper_limit="45"/>
                    <measurement group_id="B3" value="32.5" lower_limit="18" upper_limit="39"/>
                    <measurement group_id="B4" value="35.9" lower_limit="23" upper_limit="45"/>
                    <measurement group_id="B5" value="33.2" lower_limit="18" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="163.19" lower_limit="151.0" upper_limit="175.0"/>
                    <measurement group_id="B2" value="164.06" lower_limit="151.0" upper_limit="177.0"/>
                    <measurement group_id="B3" value="173.81" lower_limit="165.0" upper_limit="189.0"/>
                    <measurement group_id="B4" value="175.38" lower_limit="163.0" upper_limit="187.0"/>
                    <measurement group_id="B5" value="169.11" lower_limit="151" upper_limit="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.38" lower_limit="55.4" upper_limit="73.5"/>
                    <measurement group_id="B2" value="66.51" lower_limit="55.8" upper_limit="73.4"/>
                    <measurement group_id="B3" value="86.39" lower_limit="74.9" upper_limit="108.8"/>
                    <measurement group_id="B4" value="84.68" lower_limit="75.3" upper_limit="106.8"/>
                    <measurement group_id="B5" value="75.49" lower_limit="55.4" upper_limit="108.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>BMI = weight (kg)/[height (m)^2]</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.271" lower_limit="19.31" upper_limit="30.72"/>
                    <measurement group_id="B2" value="24.891" lower_limit="20.12" upper_limit="30.25"/>
                    <measurement group_id="B3" value="28.558" lower_limit="23.98" upper_limit="31.81"/>
                    <measurement group_id="B4" value="27.530" lower_limit="22.99" upper_limit="31.41"/>
                    <measurement group_id="B5" value="26.313" lower_limit="19.31" upper_limit="31.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide</title>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>Pharmacokinetic (PK) Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide</title>
          <population>Pharmacokinetic (PK) Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
          <units>ng*hour/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217.2" spread="21.0"/>
                    <measurement group_id="O2" value="237.2" spread="22.1"/>
                    <measurement group_id="O3" value="221.9" spread="21.2"/>
                    <measurement group_id="O4" value="253.0" spread="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence between pen injector and syringe injection was to be considered established if the 90% confidence interval (CI) of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>109.22</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>104.83</ci_lower_limit>
            <ci_upper_limit>113.80</ci_upper_limit>
            <estimate_desc>The analysis was performed using Proc Mixed in statistical software suite (SAS), with treatment, sequence, period, and participant within sequence as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>113.99</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>108.32</ci_lower_limit>
            <ci_upper_limit>119.95</ci_upper_limit>
            <estimate_desc>The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of Teduglutide</title>
        <description>Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of Teduglutide</title>
          <description>Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.90" spread="37.7"/>
                    <measurement group_id="O2" value="33.31" spread="37.6"/>
                    <measurement group_id="O3" value="31.99" spread="34.8"/>
                    <measurement group_id="O4" value="29.58" spread="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>98.27</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>88.50</ci_lower_limit>
            <ci_upper_limit>109.11</ci_upper_limit>
            <estimate_desc>The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>92.48</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>83.80</ci_lower_limit>
            <ci_upper_limit>102.05</ci_upper_limit>
            <estimate_desc>The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide</title>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide</title>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="227.6" spread="21.1"/>
                    <measurement group_id="O2" value="249.2" spread="20.8"/>
                    <measurement group_id="O3" value="227.1" spread="20.8"/>
                    <measurement group_id="O4" value="268.2" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>109.44</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>105.51</ci_lower_limit>
            <ci_upper_limit>113.51</ci_upper_limit>
            <estimate_desc>The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence between pen injector and syringe injection was to be considered established if the 90% CI of the corresponding geometric mean ratio was within the acceptance interval of 80.00% to 125.00%.</non_inferiority_desc>
            <param_type>Geometric Mean Ratio</param_type>
            <param_value>118.40</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>112.31</ci_lower_limit>
            <ci_upper_limit>124.83</ci_upper_limit>
            <estimate_desc>The analysis was performed using Proc Mixed in SAS, with treatment, sequence, period, and participant within sequence as fixed effects.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide by Injection Site</title>
        <description>AUC0-last of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Abdomen</title>
            <description>Teduglutide, 3 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm</title>
            <description>Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh</title>
            <description>Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O8">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O9">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O10">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen</title>
            <description>Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O11">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm</title>
            <description>Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O12">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh</title>
            <description>Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide by Injection Site</title>
          <description>AUC0-last of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="10"/>
                <count group_id="O9" value="10"/>
                <count group_id="O10" value="12"/>
                <count group_id="O11" value="10"/>
                <count group_id="O12" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="241.2" spread="14.0"/>
                    <measurement group_id="O2" value="205.8" spread="29.1"/>
                    <measurement group_id="O3" value="202.2" spread="14.4"/>
                    <measurement group_id="O4" value="277.6" spread="9.1"/>
                    <measurement group_id="O5" value="216.6" spread="27.8"/>
                    <measurement group_id="O6" value="215.2" spread="16.7"/>
                    <measurement group_id="O7" value="219.6" spread="17.2"/>
                    <measurement group_id="O8" value="222.6" spread="27.9"/>
                    <measurement group_id="O9" value="224.1" spread="20.3"/>
                    <measurement group_id="O10" value="239.5" spread="19.0"/>
                    <measurement group_id="O11" value="277.3" spread="23.3"/>
                    <measurement group_id="O12" value="246.4" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site</title>
        <description>Cmax of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Abdomen</title>
            <description>Teduglutide, 3 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm</title>
            <description>Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh</title>
            <description>Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O8">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O9">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O10">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen</title>
            <description>Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O11">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm</title>
            <description>Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O12">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh</title>
            <description>Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site</title>
          <description>Cmax of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="10"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="10"/>
                <count group_id="O9" value="10"/>
                <count group_id="O10" value="12"/>
                <count group_id="O11" value="10"/>
                <count group_id="O12" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.84" spread="29.7"/>
                    <measurement group_id="O2" value="31.66" spread="41.6"/>
                    <measurement group_id="O3" value="29.02" spread="35.2"/>
                    <measurement group_id="O4" value="43.65" spread="20.7"/>
                    <measurement group_id="O5" value="28.73" spread="43.9"/>
                    <measurement group_id="O6" value="27.91" spread="27.3"/>
                    <measurement group_id="O7" value="26.86" spread="25.9"/>
                    <measurement group_id="O8" value="38.28" spread="43.8"/>
                    <measurement group_id="O9" value="32.97" spread="25.0"/>
                    <measurement group_id="O10" value="28.14" spread="30.4"/>
                    <measurement group_id="O11" value="32.33" spread="33.8"/>
                    <measurement group_id="O12" value="28.73" spread="35.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site</title>
        <description>AUC0-infinity of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Abdomen</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Arm</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 1 (Teduglutide 3 mg): Syringe Injection in Thigh</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Abdomen</title>
            <description>Teduglutide, 3 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O5">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Arm</title>
            <description>Teduglutide, 3 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O6">
            <title>Cohort 1 (Teduglutide 3 mg): Pen Injector in Thigh</title>
            <description>Teduglutide, 3 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O7">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Abdomen</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O8">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Arm</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the arm, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O9">
            <title>Cohort 2 (Teduglutide 4 mg): Syringe Injection in Thigh</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.Teduglutide, 4 mg, SC injection using a syringe in the abdomen, once on Day 1 of either Treatment Period 1 or Treatment Period 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O10">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Abdomen</title>
            <description>Teduglutide, 4 mg, SC pen injector in the abdomen, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O11">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Arm</title>
            <description>Teduglutide, 4 mg, SC pen injector in the arm, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O12">
            <title>Cohort 2 (Teduglutide 4 mg): Pen Injector in Thigh</title>
            <description>Teduglutide, 4 mg, SC pen injector in the thigh, once on Day 1 of Treatment Period 1 and 2. Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site</title>
          <description>AUC0-infinity of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.</description>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="9"/>
                <count group_id="O9" value="9"/>
                <count group_id="O10" value="12"/>
                <count group_id="O11" value="9"/>
                <count group_id="O12" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="246.6" spread="13.2"/>
                    <measurement group_id="O2" value="213.0" spread="29.5"/>
                    <measurement group_id="O3" value="218.6" spread="18.7"/>
                    <measurement group_id="O4" value="282.3" spread="9.1"/>
                    <measurement group_id="O5" value="229.6" spread="26.8"/>
                    <measurement group_id="O6" value="229.2" spread="18.6"/>
                    <measurement group_id="O7" value="224.7" spread="17.6"/>
                    <measurement group_id="O8" value="228.2" spread="27.1"/>
                    <measurement group_id="O9" value="228.7" spread="20.0"/>
                    <measurement group_id="O10" value="247.0" spread="19.7"/>
                    <measurement group_id="O11" value="296.8" spread="24.4"/>
                    <measurement group_id="O12" value="268.1" spread="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide</title>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide</title>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.002" lower_limit="2.00" upper_limit="8.06"/>
                    <measurement group_id="O2" value="4.001" lower_limit="0.50" upper_limit="8.05"/>
                    <measurement group_id="O3" value="4.999" lower_limit="2.01" upper_limit="8.04"/>
                    <measurement group_id="O4" value="4.507" lower_limit="2.00" upper_limit="12.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide</title>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide</title>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
          <units>1/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4055" spread="51.2"/>
                    <measurement group_id="O2" value="0.4191" spread="41.0"/>
                    <measurement group_id="O3" value="0.3971" spread="41.8"/>
                    <measurement group_id="O4" value="0.3236" spread="48.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide</title>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide</title>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.930" spread="1.1070"/>
                    <measurement group_id="O2" value="1.797" spread="0.8341"/>
                    <measurement group_id="O3" value="1.903" spread="0.9107"/>
                    <measurement group_id="O4" value="2.385" spread="1.2292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Total Body Clearance (CL/F) of Teduglutide</title>
        <description>CL/F for extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.</description>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Body Clearance (CL/F) of Teduglutide</title>
          <description>CL/F for extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.</description>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
          <units>Liter(L)/hr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.48" spread="3.2060"/>
                    <measurement group_id="O2" value="12.31" spread="2.9332"/>
                    <measurement group_id="O3" value="17.97" spread="3.5737"/>
                    <measurement group_id="O4" value="15.27" spread="3.5042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Volume of Distribution (Vz/F) of Teduglutide</title>
        <description>Vz/F associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.</description>
        <time_frame>Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2</time_frame>
        <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (Vz/F) of Teduglutide</title>
          <description>Vz/F associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.</description>
          <population>PK Set included all participants who received at least one dose of the study drug and have at least 1 quantifiable plasma concentration. Overall number of participants analyzed are the number of participants with data available for analyses.</population>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.85" spread="18.837"/>
                    <measurement group_id="O2" value="31.86" spread="15.382"/>
                    <measurement group_id="O3" value="49.84" spread="27.394"/>
                    <measurement group_id="O4" value="51.01" spread="23.867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. Number of participants with TEAEs included injection site reactions and injection site injury assessments.</description>
        <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
        <population>Safety Set included all participants who received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. Number of participants with TEAEs included injection site reactions and injection site injury assessments.</description>
          <population>Safety Set included all participants who received at least one dose of the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Change in Vital Signs</title>
        <description>Vital signs included body temperature, respiratory rate, blood pressure, and heart rate.</description>
        <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
        <population>Safety Set included all participants who received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change in Vital Signs</title>
          <description>Vital signs included body temperature, respiratory rate, blood pressure, and heart rate.</description>
          <population>Safety Set included all participants who received at least one dose of the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments</title>
        <description>Clinical laboratory assessments included hematology, serum chemistry, coagulation, and urinalysis. Changes in laboratory values may be considered as AE if they were judged to be clinically significant.</description>
        <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
        <population>Safety Set included all participants who received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments</title>
          <description>Clinical laboratory assessments included hematology, serum chemistry, coagulation, and urinalysis. Changes in laboratory values may be considered as AE if they were judged to be clinically significant.</description>
          <population>Safety Set included all participants who received at least one dose of the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes in Physical Examinations</title>
        <description>Physical examination included examination of respiratory, cardiovascular, and gastrointestinal system.</description>
        <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
        <population>Safety Set included all participants who received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection))</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes in Physical Examinations</title>
          <description>Physical examination included examination of respiratory, cardiovascular, and gastrointestinal system.</description>
          <population>Safety Set included all participants who received at least one dose of the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Device Malfunction</title>
        <description>Number of participants with device malfunction was assessed and reported. The site staff reported any malfunctions whilst using the device.</description>
        <time_frame>Day 1</time_frame>
        <population>Safety Set included all participants who received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
            <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
            <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
            <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
            <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Device Malfunction</title>
          <description>Number of participants with device malfunction was assessed and reported. The site staff reported any malfunctions whilst using the device.</description>
          <population>Safety Set included all participants who received at least one dose of the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the start of study drug administration up to follow-up (up to 42 days)</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. AEs were collected and reported as per Treatment (A1, B1, A2, and B2) throughout the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1 (Teduglutide 3 mg): Treatment A1 (Syringe Injection)</title>
          <description>Teduglutide, 3 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 1 (Teduglutide 3 mg): Treatment B1 (Pen Injector)</title>
          <description>Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B1). Participants with &gt;=40.0 kg to &lt;=75.0 kg of weight were included in Cohort 1.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 2 (Teduglutide 4 mg): Treatment A2 (Syringe Injection)</title>
          <description>Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 and 2 (Treatment A2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 2 (Teduglutide 4 mg): Treatment B2 (Pen Injector)</title>
          <description>Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 and 2 (Treatment B2). Participants &gt;75.0 kg to &lt;=120.0 kg of weight were included in Cohort 2.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Vessel puncture site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@takeda.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04465396
org study id: TAK-633-1001
nct id: NCT04465396
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to evaluate the bioavailability of teduglutide administered as a
      single subcutaneous (SC) fixed dose (depending upon participant weightband assignment)
      delivered by a syringe injection and the same fixed dose delivered by the pen injector in
      healthy participants.
This is a 2-period crossover study and consists of two cohorts. Cohort 1 consists of
      participant's with greater than or equal to (>=) 40.0 kilogram (kg) to lesser than or equal
      to (<=) 75.0 kg of weight and Cohort 2 consists of participant's with greater than (>) 75.0
      kg to <= 120.0 kg of weight. Participants in each cohort will be randomized to 1 of 2
      treatment sequences AB or BA. Randomization will be stratified by injection site (i.e.,
      thigh, abdomen, and arm) within each cohort.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
measure: Maximum Observed Plasma Concentration (Cmax) of Teduglutide
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
description: Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
measure: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
measure: Area Under the Plasma Concentration Verse Time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last) of Teduglutide by Injection Site
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
description: AUC0-last of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
measure: Maximum Observed Plasma Concentration (Cmax) of Teduglutide by Injection Site
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
description: Cmax of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
measure: Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-infinity) of Teduglutide by Injection Site
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
description: AUC0-infinity of teduglutide by injection site (i.e., thigh, abdomen, and arm) was assessed and reported.
measure: Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) [Tmax] of Teduglutide
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
measure: Terminal Disposition Phase Rate Constant (Lambda z) of Teduglutide
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
measure: Terminal Disposition Phase Half-Life (t1/2z) of Teduglutide
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
measure: Apparent Total Body Clearance (CL/F) of Teduglutide
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
description: CL/F for extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.
measure: Apparent Volume of Distribution (Vz/F) of Teduglutide
time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24 hours post-dose of Treatment Period 1 and Treatment Period 2
description: Vz/F associated with the terminal slope following extravascular administration divided by the fraction of dose absorbed of teduglutide was assessed and reported.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: From the start of study drug administration up to follow-up (up to 42 days)
description: An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. Number of participants with TEAEs included injection site reactions and injection site injury assessments.
measure: Number of Participants With Clinically Significant Change in Vital Signs
time frame: From the start of study drug administration up to follow-up (up to 42 days)
description: Vital signs included body temperature, respiratory rate, blood pressure, and heart rate.
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
time frame: From the start of study drug administration up to follow-up (up to 42 days)
description: Clinical laboratory assessments included hematology, serum chemistry, coagulation, and urinalysis. Changes in laboratory values may be considered as AE if they were judged to be clinically significant.
measure: Number of Participants With Clinically Significant Changes in Physical Examinations
time frame: From the start of study drug administration up to follow-up (up to 42 days)
description: Physical examination included examination of respiratory, cardiovascular, and gastrointestinal system.
measure: Number of Participants With Device Malfunction
time frame: Day 1
description: Number of participants with device malfunction was assessed and reported. The site staff reported any malfunctions whilst using the device.
arm group label: Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)
arm group type: Experimental
description: Teduglutide, 3 mg, subcutaneous (SC) injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A1), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B1). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants with >=40.0 kg to <=75.0 kg of weight were included in Cohort 1.
arm group label: Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)
arm group type: Experimental
description: Teduglutide, 3 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B1), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A1). A Washout Period of 7 days was maintained between the Treatment Periods 1 and 2. Participants with >=40.0 kg to <=75.0 kg of weight were included in Cohort 1.
arm group label: Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)
arm group type: Experimental
description: Teduglutide, 4 mg, SC injection using a syringe, once on Day 1 of Treatment Period 1 (Treatment A2), followed by same dose SC pen injector, once on Day 1 of Treatment Period 2 (Treatment B2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants >75.0 kg to <=120.0 kg of weight were included in Cohort 2.
arm group label: Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)
arm group type: Experimental
description: Teduglutide, 4 mg, SC pen injector, once on Day 1 of Treatment Period 1 (Treatment B2), followed by same dose SC injection using a syringe, once on Day 1 of Treatment Period 2 (Treatment A2). A Washout Period of 7 days was maintained between Treatment Periods 1 and 2. Participants >75.0 kg to <=120.0 kg of weight were included in Cohort 2.
intervention type: Drug
intervention name: Teduglutide
description: Participants received 3 mg or 4 mg of Teduglutide SC syringe injection followed by pen injector or vice versa depending upon the treatment sequence AB or BA on Day 1 of Treatment Periods 1 and 2.
arm group label: Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)
arm group label: Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)
arm group label: Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)
arm group label: Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)
other name: TAK-633
intervention type: Device
intervention name: Syringe Injection
description: Teduglutide was administered using syringe.
arm group label: Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)
arm group label: Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)
arm group label: Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)
arm group label: Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)
intervention type: Device
intervention name: Pen injector
description: Teduglutide was administered using pen injector.
arm group label: Cohort 1 (Teduglutide 3 mg): Treatment A1, Then Treatment B1 (A1B1)
arm group label: Cohort 1 (Teduglutide 3 mg): Treatment B1, Then Treatment A1 (B1A1)
arm group label: Cohort 2 (Teduglutide 4 mg): Treatment A2, Then Treatment B2 (A2B2)
arm group label: Cohort 2 (Teduglutide 4 mg): Treatment B2, Then Treatment A2 (B2A2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
country: United States
url: https://clinicaltrials.takeda.com/study-detail/5f6b600d4db2bf003ab48ce5
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Teduglutide
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 