xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06021951</url>
    </required_header>
    <id_info>
      <org_study_id>1002FDC-075</org_study_id>
      <nct_id>NCT06021951</nct_id>
    </id_info>
    <brief_title>Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women</brief_title>
    <official_title>An Open-Label Postmarking Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid and Ezetimibe in the Breast Milk of Healthy Lactating Women Administered Therapeutic Doses of Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Esperion Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Esperion Therapeutics, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and&#xD;
        ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the&#xD;
        breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of&#xD;
        bempedoic acid or bempedoic acid and ezetimibe in breast milk after 6 consecutive daily doses&#xD;
        of bempedoic acid or bempedoic acid/ezetimibe FCDP.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Post marketing approval commitment for the FDA&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Daily infant dose (mg/d)</measure>
      <time_frame>Day 6</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Relative infant dose (%)</measure>
      <time_frame>Day 6</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Amount excreted in each breast milk collection, calculated as the product of concentration and milk volume collected</measure>
      <time_frame>Day 6</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the milk concentration-time curve (AUC) over a 24-hour collection interval</measure>
      <time_frame>Day 6</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average milk concentration based on milk AUC</measure>
      <time_frame>Day 6</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak and trough milk concentrations and the time of peak milk concentrations</measure>
      <time_frame>Day 6</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma trough concentrations</measure>
      <time_frame>Day 6</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">16</enrollment>
    <condition>Healthy Lactating Women</condition>
    <arm_group>
      <arm_group_label>Bempedoic acid</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Bempedoic acid/ezetimibe fixed combination drug product</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bempedoic Acid 180 MG Oral Tablet</intervention_name>
      <description>Bempedoic Acid 180 MG Oral Tablet [Nexletol]</description>
      <arm_group_label>Bempedoic acid</arm_group_label>
      <other_name>Nexletol</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet</intervention_name>
      <description>Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet [NEXLIZET]</description>
      <arm_group_label>Bempedoic acid/ezetimibe fixed combination drug product</arm_group_label>
      <other_name>Nexlizet 180 mg-10 mg</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The subject must be a lactating female who had a normal full-term pregnancy and has&#xD;
               been actively breastfeeding or pumping for at least 4 weeks; lactation must be well&#xD;
               established per Investigator discretion.&#xD;
  &#xD;
            -  The subject must be willing to pump regularly during the study to maintain milk supply&#xD;
               and discontinue breastfeeding for the entire 13-day Treatment and Washout Periods.&#xD;
  &#xD;
            -  The subject must not be pregnant.&#xD;
  &#xD;
            -  The subject must be surgically sterile or willing to use 1 acceptable method of birth&#xD;
               control.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has clinically significant infection (e.g., pneumonia, pyelonephritis) or chronic&#xD;
               infection within 30 days prior to enrollment.&#xD;
  &#xD;
            -  Has evidence of unstable or uncontrolled, clinically significant cardiovascular,&#xD;
               central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary,&#xD;
               hematological, coagulation, immunological, endocrine/metabolic, or other medical&#xD;
               disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures, or&#xD;
               allergic skin rash, that, in the opinion of the Investigator, would confound the study&#xD;
               results or compromise subject safety.&#xD;
  &#xD;
            -  Has estimated glomerular filtration rate (eGFR) &lt;30 mL/min/1.732 using the&#xD;
               Modification of Diet in Renal Disease (MDRD) formula.&#xD;
  &#xD;
            -  Has liver disease or dysfunction characterized by Child-Pugh Class B or Class C.&#xD;
  &#xD;
            -  History of any major neurological disorders, including stroke, multiple sclerosis,&#xD;
               brain tumor, or neurodegenerative disease.&#xD;
  &#xD;
            -  Has active psychiatric problems that, in the Investigator's opinion, may interfere&#xD;
               with compliance with the study procedures.&#xD;
  &#xD;
            -  Has history of breast implants, breast augmentation, or breast reduction surgery.&#xD;
  &#xD;
            -  Has a prior history of difficulty establishing lactation.&#xD;
  &#xD;
            -  Gastrointestinal conditions or procedures (including weight loss surgery; e.g.,&#xD;
               Lap-Band® or gastric bypass) that may affect drug absorption.&#xD;
  &#xD;
            -  Any history of malignancy (with the exception only of basal or squamous cell carcinoma&#xD;
               of the skin in individuals that have been cancer free for &gt;5 years).&#xD;
  &#xD;
            -  History within the last 2 years of drug, alcohol, amphetamine and derivatives, or&#xD;
               cocaine abuse.&#xD;
  &#xD;
            -  Current smoker.&#xD;
  &#xD;
            -  Blood donation, participation in a multiple blood draw clinical study, major trauma,&#xD;
               or surgery with or without blood loss within 30 days prior to enrollment.&#xD;
  &#xD;
            -  Blood transfusion for any reason within 90 days prior to enrollment.&#xD;
  &#xD;
            -  Use of any 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor&#xD;
               (statin) concurrently or within 30 days prior to randomization.&#xD;
  &#xD;
            -  Use of cyclosporine, cholestyramine, probenecid, fibrate drugs, or medications&#xD;
               contraindicated during lactation concurrently or within 30 days prior to&#xD;
               randomization.&#xD;
  &#xD;
            -  Concomitant use or use within 30 days prior to randomization of drugs that decrease&#xD;
               breast milk production, such as pseudoephedrine.&#xD;
  &#xD;
            -  Concomitant use or use within 30 days prior to randomization of drugs that increase&#xD;
               breast milk production, such as domperidone.&#xD;
  &#xD;
            -  Use of any experimental or investigational drugs/vaccines concurrently or within 30&#xD;
               days or 5 half-lives of the drug, whichever is longer, prior to screening.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christine Broestl, MS</last_name>
      <role>Study Director</role>
      <affiliation>Esperion Therapeutics, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Esperion Medical Information</last_name>
      <phone>883-377-7633</phone>
      <email>medinfo@esperion.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>PPD Development, Las Vegas Research Unit</name>
        <address>
          <city>Las Vegas</city>
          <state>Nevada</state>
          <zip>89113</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Study Coordinator</last_name>
      </contact>
      <contact_backup>
        <phone>512-462-0492</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bempedoic acid</keyword>
    <keyword>Ezetimibe</keyword>
    <keyword>Bempedoic acid and ezetimibe</keyword>
    <keyword>Breast Milk</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid</mesh_term>
      <mesh_term>Ezetimibe</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06021951
  org study id: 1002FDC-075
  nct id: NCT06021951
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and
        ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the
        breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of
        bempedoic acid or bempedoic acid and ezetimibe in breast milk after 6 consecutive daily doses
        of bempedoic acid or bempedoic acid/ezetimibe FCDP.
  Post marketing approval commitment for the FDA
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Daily infant dose (mg/d)
  time frame: Day 6
  measure: Relative infant dose (%)
  time frame: Day 6
  measure: Amount excreted in each breast milk collection, calculated as the product of concentration and milk volume collected
  time frame: Day 6
  measure: Area under the milk concentration-time curve (AUC) over a 24-hour collection interval
  time frame: Day 6
  measure: Average milk concentration based on milk AUC
  time frame: Day 6
  measure: Peak and trough milk concentrations and the time of peak milk concentrations
  time frame: Day 6
  measure: Plasma trough concentrations
  time frame: Day 6
  arm group label: Bempedoic acid
  arm group type: Experimental
  arm group label: Bempedoic acid/ezetimibe fixed combination drug product
  arm group type: Experimental
  intervention type: Drug
  intervention name: Bempedoic Acid 180 MG Oral Tablet
  description: Bempedoic Acid 180 MG Oral Tablet [Nexletol]
  arm group label: Bempedoic acid
  other name: Nexletol
  intervention type: Drug
  intervention name: Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
  description: Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet [NEXLIZET]
  arm group label: Bempedoic acid/ezetimibe fixed combination drug product
  other name: Nexlizet 180 mg-10 mg
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Christine Broestl, MS
  role: Study Director
  affiliation: Esperion Therapeutics, Inc.
  last name: Esperion Medical Information
  phone: 883-377-7633
  email: medinfo@esperion.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor
  mesh term: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
  mesh term: Ezetimibe
  sharing ipd: No