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/NCT05965570</url>
    </required_header>
    <id_info>
      <org_study_id>INS1007-109</org_study_id>
      <nct_id>NCT05965570</nct_id>
    </id_info>
    <brief_title>A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants</brief_title>
    <official_title>A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Insmed Incorporated</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Insmed Incorporated</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 purpose of this study is to determine the effect of clarithromycin on the&#xD;
        single-dose pharmacokinetics (PK) of brensocatib in healthy participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">September 14, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 14, 2023</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib</measure>
      <time_frame>Pre-dose and at multiple timepoints post-dose on Days 1 to 8, and Days 13 to 20</time_frame>
      <description>The effect of clarithromycin on the single dose pharmacokinetics of brensocatib will be assessed in healthy participants.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants who Experienced at Least one Adverse Event (AE)</measure>
      <time_frame>Up to Day 27</time_frame>
      <description>Determination of the safety and tolerability of a single oral dose of brensocatib when administered alone and with clarithromycin in healthy participants.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">22</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Brensocatib + Clarithromycin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a single oral dose of brensocatib in the morning on Days 1 and 13 after an overnight fast, and oral doses of clarithromycin, twice daily (BID), with food on Days 8 to 19. On Day 13, brensocatib will be coadministered with the morning dose of clarithromycin. Clarithromycin can be taken with food, with the exception of the morning dose on the day of coadministration with brensocatib (Day 13), which will be taken after an overnight fast.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Brensocatib</intervention_name>
      <description>Oral tablets.</description>
      <arm_group_label>Brensocatib + Clarithromycin</arm_group_label>
      <other_name>INS1007</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Clarithromycin</intervention_name>
      <description>Oral tablets.</description>
      <arm_group_label>Brensocatib + Clarithromycin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Females of nonchildbearing potential and males, of any race, between 18 and 65 years&#xD;
               of age, inclusive, without current disease.&#xD;
  &#xD;
            -  Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m^2), inclusive,&#xD;
               and a total body weight ≥50 kilograms (kg).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Significant history or clinical manifestation of any metabolic, allergic,&#xD;
               dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,&#xD;
               gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as&#xD;
               determined by the investigator (or designee).&#xD;
  &#xD;
            -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
               food, or other substance, unless approved by the investigator (or designee).&#xD;
  &#xD;
            -  History of stomach or intestinal surgery or resection that would potentially alter&#xD;
               absorption and/or excretion of orally administered drugs (uncomplicated appendectomy&#xD;
               and hernia repair will be allowed; cholecystectomy will not be allowed).&#xD;
  &#xD;
            -  Positive serology test results for hepatitis B panel or hepatitis C antibody and/or&#xD;
               reactive human immunodeficiency virus 1/2 test.&#xD;
  &#xD;
            -  Participants whose results are compatible with prior immunization for hepatitis B or&#xD;
               natural immunity may be included at the discretion of the investigator.&#xD;
  &#xD;
            -  Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at&#xD;
               screening or check-in.&#xD;
  &#xD;
            -  Poor peripheral venous access. Note: Other inclusion/exclusion criteria may apply.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Insmed Medical Information</last_name>
      <phone>1-844-446-7633</phone>
      <email>medicalinformation@insmed.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>USA001</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75247</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Clarithromycin</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/NCT05965570
  org study id: INS1007-109
  nct id: NCT05965570
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary purpose of this study is to determine the effect of clarithromycin on the
        single-dose pharmacokinetics (PK) of brensocatib in healthy participants.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Area Under the Plasma Concentration-time Curve (AUC) of Brensocatib
  time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 8, and Days 13 to 20
  description: The effect of clarithromycin on the single dose pharmacokinetics of brensocatib will be assessed in healthy participants.
  measure: Number of Participants who Experienced at Least one Adverse Event (AE)
  time frame: Up to Day 27
  description: Determination of the safety and tolerability of a single oral dose of brensocatib when administered alone and with clarithromycin in healthy participants.
  arm group label: Brensocatib + Clarithromycin
  arm group type: Experimental
  description: Participants will receive a single oral dose of brensocatib in the morning on Days 1 and 13 after an overnight fast, and oral doses of clarithromycin, twice daily (BID), with food on Days 8 to 19. On Day 13, brensocatib will be coadministered with the morning dose of clarithromycin. Clarithromycin can be taken with food, with the exception of the morning dose on the day of coadministration with brensocatib (Day 13), which will be taken after an overnight fast.
  intervention type: Drug
  intervention name: Brensocatib
  description: Oral tablets.
  arm group label: Brensocatib + Clarithromycin
  other name: INS1007
  intervention type: Drug
  intervention name: Clarithromycin
  description: Oral tablets.
  arm group label: Brensocatib + Clarithromycin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Insmed Medical Information
  phone: 1-844-446-7633
  email: medicalinformation@insmed.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Clarithromycin
  sharing ipd: No