<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/NCT04460586</url>
  </required_header>
  <id_info>
    <org_study_id>HS-20-00513</org_study_id>
    <nct_id>NCT04460586</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Omadacycline in Cystic Fibrosis</brief_title>
  <official_title>Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paul Beringer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Paratek Pharmaceuticals Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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 purpose of this study is to characterize the pharmacokinetics of intravenous and oral&#xD;
      omadacycline in patients with cystic fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Omadacycline exhibits excellent activity against bacteria including methicillin-resistant&#xD;
      Staphylococcus aureus (MRSA), Burkholderia cepacia, and Nontuberculous mycobacteria (NTM)&#xD;
      that are a potential source of lung infection in CF patients. As omadacycline demonstrates&#xD;
      antimicrobial activity against a number of pathogens in CF, the investigators hope to learn&#xD;
      the optimal dose of omadacycline necessary to treat lung infections in patients with CF in&#xD;
      the future. The study hypothesis is that omadacycline will exhibit good oral bioavailability&#xD;
      in patients with CF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>A single group of patients with CF will receive a single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of 300 mg PO.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>3 Days</time_frame>
    <description>To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>3 days</time_frame>
    <description>To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>3 days</time_frame>
    <description>To assess the area under the plasma concentration time curve of omadacycline after single dose of oral and intravenous administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute Bioavailability</measure>
    <time_frame>6 days</time_frame>
    <description>To determine the absolute bioavailability of omadacycline following single dose of IV and PO administration.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>Omadacycline IV followed by PO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omadacycline 100mg IV, Omadacycline 300 mg tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omadacycline Injection [Nuzyra]</intervention_name>
    <description>Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.</description>
    <arm_group_label>Omadacycline IV followed by PO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omadacycline Oral Tablet [Nuzyra]</intervention_name>
    <description>Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.</description>
    <arm_group_label>Omadacycline IV followed by PO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of CF based on positive sweat chloride or known CF mutation&#xD;
&#xD;
          -  Age &gt;=18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of an ongoing acute pulmonary exacerbation defined based on clinical signs &amp;&#xD;
             symptoms and an acute decline in relative FEV1 of 10% or greater.&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Serious past allergy to a tetracycline antibiotic&#xD;
&#xD;
          -  No alcohol, nicotine, or caffeine-containing products during the study period&#xD;
&#xD;
          -  Hemoglobin &lt; 8 g/dL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adupa P Rao, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Keck Medicine of USC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paul M. Beringer, PharmD</last_name>
    <phone>323-442-1402</phone>
    <email>beringer@usc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul M. Beringer, PharmD</last_name>
      <phone>323-442-1402</phone>
      <email>beringer@usc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Paul Beringer</investigator_full_name>
    <investigator_title>Professor of Clinical Pharmacy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_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/NCT04460586
org study id: HS-20-00513
nct id: NCT04460586
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral
      omadacycline in patients with cystic fibrosis.
Omadacycline exhibits excellent activity against bacteria including methicillin-resistant
      Staphylococcus aureus (MRSA), Burkholderia cepacia, and Nontuberculous mycobacteria (NTM)
      that are a potential source of lung infection in CF patients. As omadacycline demonstrates
      antimicrobial activity against a number of pathogens in CF, the investigators hope to learn
      the optimal dose of omadacycline necessary to treat lung infections in patients with CF in
      the future. The study hypothesis is that omadacycline will exhibit good oral bioavailability
      in patients with CF.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A single group of patients with CF will receive a single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of 300 mg PO.
primary purpose: Other
masking: None (Open Label)
measure: Cmax
time frame: 3 Days
description: To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.
measure: Tmax
time frame: 3 days
description: To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.
measure: AUC
time frame: 3 days
description: To assess the area under the plasma concentration time curve of omadacycline after single dose of oral and intravenous administration.
measure: Absolute Bioavailability
time frame: 6 days
description: To determine the absolute bioavailability of omadacycline following single dose of IV and PO administration.
arm group label: Omadacycline IV followed by PO
arm group type: Experimental
description: Omadacycline 100mg IV, Omadacycline 300 mg tablet
intervention type: Drug
intervention name: Omadacycline Injection [Nuzyra]
description: Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
arm group label: Omadacycline IV followed by PO
intervention type: Drug
intervention name: Omadacycline Oral Tablet [Nuzyra]
description: Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
arm group label: Omadacycline IV followed by PO
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adupa P Rao, M.D.
role: Study Director
affiliation: Keck Medicine of USC
last name: Paul M. Beringer, PharmD
phone: 323-442-1402
email: beringer@usc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Southern California
investigator full name: Paul Beringer
investigator title: Professor of Clinical Pharmacy
mesh term: Cystic Fibrosis
mesh term: Fibrosis