<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/NCT04470908</url>
  </required_header>
  <id_info>
    <org_study_id>BGB-3111-112</org_study_id>
    <nct_id>NCT04470908</nct_id>
  </id_info>
  <brief_title>The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males</brief_title>
  <official_title>A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effect of the Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BeiGene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BeiGene</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 determine the effect of the moderate cytochrome&#xD;
      P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy&#xD;
      males.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 24, 2020</start_date>
  <completion_date type="Actual">November 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</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 Curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t) of zanubrutinib</measure>
    <time_frame>Days 1 and 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC from time zero to infinity (AUC0-∞) of zanubrutinib</measure>
    <time_frame>Days 1 and 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed plasma concentration (Cmax) of zanubrutinib</measure>
    <time_frame>Days 1 and 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to the maximum observed plasma concentration (Tmax) of zanubrutinib</measure>
    <time_frame>Days 1 and 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal elimination half-life (t1/2) of zanubrutinib</measure>
    <time_frame>Days 1 and 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent oral clearance (CL/F) of zanubrutinib</measure>
    <time_frame>Days 1 and 11</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution (Vz/F) of zanubrutinib</measure>
    <time_frame>Days 1 and 11</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing Adverse Events (AEs)</measure>
    <time_frame>Up to 19 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants experiencing Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 19 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Healthy</condition>
  <condition>Male</condition>
  <arm_group>
    <arm_group_label>Zanubrutinib + Rifabutin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: zanubrutinib&#xD;
Days 3 to 10: rifabutin&#xD;
Day 11: zanubrutinib and rifabutin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Zanubrutinib</intervention_name>
    <description>Single oral dose of 320 mg</description>
    <arm_group_label>Zanubrutinib + Rifabutin</arm_group_label>
    <other_name>BGB-3111</other_name>
    <other_name>Brukinsa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifabutin</intervention_name>
    <description>Oral dose of 300 mg once daily</description>
    <arm_group_label>Zanubrutinib + Rifabutin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Males of any race, between 18 and 65 years of age, inclusive.&#xD;
&#xD;
          2. Male participants in good health as determined by past medical history, physical&#xD;
             examination, vital signs, ECG and laboratory tests at screening&#xD;
&#xD;
          3. Must have a body mass index (BMI) between 18 and 32 kg/m2&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Participants with a clinically relevant history or presence of any clinically&#xD;
             significant disease&#xD;
&#xD;
          2. History of stomach or intestinal surgery or resection that would potentially alter&#xD;
             absorption and/or excretion of orally administered drugs (uncomplicated appendectomy,&#xD;
             cholecystectomy, and hernia repair will be allowed)&#xD;
&#xD;
          3. History of drug or alcohol abuse within 1 year prior to check-in&#xD;
&#xD;
          4. Use or intended use of any nonprescription medications/products including vitamins,&#xD;
             minerals, herbal/plant-derived preparations within 7 days prior to check-in&#xD;
&#xD;
          5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result and/or a&#xD;
             positive human immunodeficiency virus (HIV) at screening&#xD;
&#xD;
          6. Use of tobacco- or nicotine-containing products within 3 months prior to check-in&#xD;
&#xD;
          7. Use or intended use of any prescription medications/products within 14 days prior to&#xD;
             check-in&#xD;
&#xD;
        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Novotny, MD</last_name>
    <role>Study Director</role>
    <affiliation>BeiGene</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Phase 1</keyword>
  <keyword>Healthy volunteers</keyword>
  <keyword>Pharmokinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rifabutin</mesh_term>
    <mesh_term>Zanubrutinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 10, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04470908
org study id: BGB-3111-112
nct id: NCT04470908
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of this study is to determine the effect of the moderate cytochrome
      P450 3A (CYP3A) inducer rifabutin on the pharmacokinetics (PK) of zanubrutinib in healthy
      males.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t) of zanubrutinib
time frame: Days 1 and 11
measure: AUC from time zero to infinity (AUC0-∞) of zanubrutinib
time frame: Days 1 and 11
measure: Maximum observed plasma concentration (Cmax) of zanubrutinib
time frame: Days 1 and 11
measure: Time to the maximum observed plasma concentration (Tmax) of zanubrutinib
time frame: Days 1 and 11
measure: Apparent terminal elimination half-life (t1/2) of zanubrutinib
time frame: Days 1 and 11
measure: Apparent oral clearance (CL/F) of zanubrutinib
time frame: Days 1 and 11
measure: Apparent volume of distribution (Vz/F) of zanubrutinib
time frame: Days 1 and 11
measure: Number of participants experiencing Adverse Events (AEs)
time frame: Up to 19 days
measure: Number of participants experiencing Serious Adverse Events (SAEs)
time frame: Up to 19 days
arm group label: Zanubrutinib + Rifabutin
arm group type: Experimental
description: Day 1: zanubrutinib
Days 3 to 10: rifabutin
Day 11: zanubrutinib and rifabutin
intervention type: Drug
intervention name: Zanubrutinib
description: Single oral dose of 320 mg
arm group label: Zanubrutinib + Rifabutin
other name: BGB-3111
other name: Brukinsa
intervention type: Drug
intervention name: Rifabutin
description: Oral dose of 300 mg once daily
arm group label: Zanubrutinib + Rifabutin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William Novotny, MD
role: Study Director
affiliation: BeiGene
facility: 
country: United States
responsible party type: Sponsor
mesh term: Rifabutin
mesh term: Zanubrutinib
sharing ipd: Yes
submitted: March 10, 2023