<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/NCT03818672</url>
  </required_header>
  <id_info>
    <org_study_id>RFPK4045</org_study_id>
    <nct_id>NCT03818672</nct_id>
  </id_info>
  <brief_title>Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects</brief_title>
  <official_title>Open Label Study to Evaluate the Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy Subjects and Subjects With Severe Hepatic Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bausch Health Americas, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bausch Health Americas, 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>
      The primary objective of this study is to characterize the steady state plasma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to characterize the steady state plasma PK of&#xD;
      rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD&#xD;
      &gt;25), as well as healthy subjects with normal hepatic function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Anticipated">May 2023</completion_date>
  <primary_completion_date type="Anticipated">May 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>7 days</time_frame>
    <description>Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of the maximum concentration (Tmax)</measure>
    <time_frame>7 days</time_frame>
    <description>Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval</measure>
    <time_frame>7 days</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Severe Hepatic Impairment</condition>
  <arm_group>
    <arm_group_label>Rifaximin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rifaximin 550 mg BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifaximin</intervention_name>
    <description>Rifaximin 550 MG BID</description>
    <arm_group_label>Rifaximin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hepatically impaired subjects will be ≥18 years of age, have a diagnosis of liver&#xD;
             cirrhosis and a MELD score of ≥19 at Screening. Note: At least 6 of the hepatically&#xD;
             impaired subjects will have a MELD score of &gt;25.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has known allergy to rifaximin, rifampin, or other rifamycins, excipients&#xD;
             and/or vehicles used in the formulation, or any other clinically significant&#xD;
             allergies.&#xD;
&#xD;
          -  Subject has participated in an investigational drug or device study within 30 days&#xD;
             prior to Day 1 (Baseline).&#xD;
&#xD;
          -  Subject has any concurrent illness (other than liver cirrhosis), disability or&#xD;
             circumstance that may affect the interpretation of clinical data, could cause&#xD;
             noncompliance with treatment or visits or otherwise contraindicates participation in&#xD;
             this study in the opinion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Varsha Bhatt</last_name>
    <role>Study Director</role>
    <affiliation>Bausch Health Companies</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tendai Merriweather</last_name>
    <phone>9085412720</phone>
    <email>tendai.merriweather@bauschhealth.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Valeant Site 01</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifaximin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03818672
org study id: RFPK4045
nct id: NCT03818672
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to characterize the steady state plasma
The primary objective of this study is to characterize the steady state plasma PK of
      rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD
      >25), as well as healthy subjects with normal hepatic function.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma concentration (Cmax)
time frame: 7 days
description: Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable
measure: Time of the maximum concentration (Tmax)
time frame: 7 days
description: Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable
measure: Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval
time frame: 7 days
description: Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable
arm group label: Rifaximin
arm group type: Experimental
description: Rifaximin 550 mg BID
intervention type: Drug
intervention name: Rifaximin
description: Rifaximin 550 MG BID
arm group label: Rifaximin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Varsha Bhatt
role: Study Director
affiliation: Bausch Health Companies
last name: Tendai Merriweather
phone: 9085412720
email: tendai.merriweather@bauschhealth.com
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Rifaximin
sharing ipd: Undecided