<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/NCT03301181</url>
  </required_header>
  <id_info>
    <org_study_id>BGB-3111-104</org_study_id>
    <nct_id>NCT03301181</nct_id>
  </id_info>
  <brief_title>Phase 1 Study to Investigate Effect of Rifampin and Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-3111 in Healthy 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>
      Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or&#xD;
      itraconazole (Part B) on the pharmacokinetics of BGB-3111&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A&#xD;
      will receive a single dose of BGB-3111 before and during consecutive daily doses of strong&#xD;
      cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of&#xD;
      BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose&#xD;
      of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor,&#xD;
      itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">November 13, 2017</completion_date>
  <primary_completion_date type="Actual">November 7, 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-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>Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters</measure>
    <time_frame>Part A: Days 1 and 10</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters</measure>
    <time_frame>Part B: Days 1 and 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety as assessed by adverse events</measure>
    <time_frame>Part A: up to 19 days: Part B: up to 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety as assessed by electrocardiogram (ECG) measurements</measure>
    <time_frame>Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy Volunteers: Asian, Non-Asian</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approximately 20 subjects to receive BGB-3111 and rifampin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approximately 20 subjects to receive BGB-3111 and itraconazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BGB-3111 (Arm A)</intervention_name>
    <description>320 mg BGB-3111 single oral dose</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rifampin</intervention_name>
    <description>600 mg rifampin once daily</description>
    <arm_group_label>Arm A</arm_group_label>
    <other_name>Rifadin, Rimactane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BGB-3111 (Arm B)</intervention_name>
    <description>Up to 80 mg BGB-3111 single oral dose</description>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Itraconazole</intervention_name>
    <description>200 mg itraconazole once daily</description>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Sporanox, Orungal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Body mass index (BMI)18 - 32 kg/m2, inclusive.&#xD;
&#xD;
          2. Subjects of Asian (first- or second-generation) and non-Asian descent.&#xD;
&#xD;
          3. In good general health as assessed by the Investigator.&#xD;
&#xD;
          4. Females must be nonpregnant and nonlactating, and females of childbearing potential&#xD;
             will agree to use required contraception.&#xD;
&#xD;
          5. Males without a vasectomy will agree to use required barrier contraception, and will&#xD;
             agree to not donate sperm from the time of the first dose of BGB-3111 until ≥90 days&#xD;
             after the last dose of BGB-3111.Able to comprehend and willing to sign consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with a clinically relevant history or presence of any clinically significant&#xD;
             disease.&#xD;
&#xD;
          2. Evidence of bacterial, viral, fungal, parasitic infections within 4 weeks prior to the&#xD;
             first dose of study drug.&#xD;
&#xD;
          3. History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food, or other substance.&#xD;
&#xD;
          4. History of stomach or intestinal surgery or resection that would potentially alter&#xD;
             absorption and/or excretion of orally administered drugs.&#xD;
&#xD;
          5. History of alcoholism or drug/chemical abuse within prior year.&#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_official>
    <last_name>William Novotny, MD</last_name>
    <role>Study Director</role>
    <affiliation>BeiGene</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West Coast Clinical Trials (WCCT)</name>
      <address>
        <city>Cypress</city>
        <state>California</state>
        <zip>90630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 29, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</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>Itraconazole</mesh_term>
    <mesh_term>Rifampin</mesh_term>
    <mesh_term>Zanubrutinib</mesh_term>
  </intervention_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/NCT03301181
org study id: BGB-3111-104
nct id: NCT03301181
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Phase 1 study in healthy subjects to determine the effect of rifampin (Part A) or
      itraconazole (Part B) on the pharmacokinetics of BGB-3111
This is a Phase 1 open-label, parallel-group study in healthy subjects. Subjects in Part A
      will receive a single dose of BGB-3111 before and during consecutive daily doses of strong
      cytochrome P450 CYP3A inducer, rifampin, to investigate its effect on the pharmacokinetics of
      BGB-3111. Following an interim data analysis, subjects in Part B will receive a single dose
      of BGB-3111 before and during consecutive daily doses of strong CYP3A inhibitor,
      itraconazole, to investigate its effect on the pharmacokinetics of BGB-3111.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Plasma concentration of BGB-3111 and rifampin to evaluate protocol specified PK parameters
time frame: Part A: Days 1 and 10
measure: Plasma concentration of BGB-3111 and itraconazole to evaluate protocol specified PK parameters
time frame: Part B: Days 1 and 6
measure: Safety as assessed by adverse events
time frame: Part A: up to 19 days: Part B: up to 14 days
measure: Safety as assessed by electrocardiogram (ECG) measurements
time frame: Part A: Days 1 and 10, from screening to end of study visit; up to Day 19; Part B: Days 1 and 6, from screening to end of study visit; up to Day 14
arm group label: Arm A
arm group type: Experimental
description: Approximately 20 subjects to receive BGB-3111 and rifampin
arm group label: Arm B
arm group type: Experimental
description: Approximately 20 subjects to receive BGB-3111 and itraconazole
intervention type: Drug
intervention name: BGB-3111 (Arm A)
description: 320 mg BGB-3111 single oral dose
arm group label: Arm A
intervention type: Drug
intervention name: Rifampin
description: 600 mg rifampin once daily
arm group label: Arm A
other name: Rifadin, Rimactane
intervention type: Drug
intervention name: BGB-3111 (Arm B)
description: Up to 80 mg BGB-3111 single oral dose
arm group label: Arm B
intervention type: Drug
intervention name: Itraconazole
description: 200 mg itraconazole once daily
arm group label: Arm B
other name: Sporanox, Orungal
criteria: 
gender: All
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: Itraconazole
mesh term: Rifampin
mesh term: Zanubrutinib