<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/NCT02220348</url>
  </required_header>
  <id_info>
    <org_study_id>LIN-PK-01</org_study_id>
    <nct_id>NCT02220348</nct_id>
  </id_info>
  <brief_title>A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically</brief_title>
  <acronym>LIN-PK-01</acronym>
  <official_title>An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Forest Laboratories</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Forest Laboratories</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the amount of linaclotide and its active metabolite&#xD;
      (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg,&#xD;
      145 μg, or 290 μg) in lactating women receiving the drug therapeutically.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2014</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk</measure>
    <time_frame>From Baseline (Day 1) to Day 4</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Breast Feeding</condition>
  <condition>Constipation</condition>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>linaclotide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linaclotide</intervention_name>
    <arm_group_label>linaclotide</arm_group_label>
    <other_name>Linzess</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a lactating female who has been actively breastfeeding or pumping for at least 4&#xD;
             weeks&#xD;
&#xD;
          -  Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with&#xD;
             Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)&#xD;
&#xD;
          -  Weaning must not be underway&#xD;
&#xD;
          -  Be willing to breastfeed or pump regularly during the study to maintain milk supply&#xD;
             and discontinue breastfeeding for the 24-hour period of breast milk collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant disease state in any body system, except for the indication&#xD;
             being treated with linaclotide&#xD;
&#xD;
          -  Any structural abnormality of the gastrointestinal (GI) tract, or a disease or&#xD;
             condition that can affect GI motility&#xD;
&#xD;
          -  Participation in any other clinical investigation using an experimental drug within 90&#xD;
             days&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramesh Boinpally, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Forest Research Institute, an affiliate of Allergan plc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Specialists Inc (DDSI)</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Linzess</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linaclotide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02220348
org study id: LIN-PK-01
nct id: NCT02220348
lead sponsor: 
has dmc: No
The purpose of this study is to determine the amount of linaclotide and its active metabolite
      (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg,
      145 μg, or 290 μg) in lactating women receiving the drug therapeutically.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
time frame: From Baseline (Day 1) to Day 4
arm group label: linaclotide
arm group type: Experimental
description: Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration
intervention type: Drug
intervention name: linaclotide
arm group label: linaclotide
other name: Linzess
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Ramesh Boinpally, PhD
role: Study Director
affiliation: Forest Research Institute, an affiliate of Allergan plc.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Constipation
mesh term: Linaclotide