<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/NCT03758339</url>
  </required_header>
  <id_info>
    <org_study_id>ONT-380-008</org_study_id>
    <nct_id>NCT03758339</nct_id>
  </id_info>
  <brief_title>A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants</brief_title>
  <official_title>A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [¹⁴C]-Tucatinib Following a Single Oral Dose in Healthy Male and Female Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cascadian Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seagen 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>
      This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib&#xD;
      while it is still in the body. Healthy participants will get one dose of tucatinib by mouth.&#xD;
      Patients will be monitored for 8-14 days after they take the dose of tucatinib.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will examine the absorption, metabolism, and excretion of tucatinib in healthy&#xD;
      individuals. Participants will receive one oral dose of tucatinib and will be followed for&#xD;
      8-14 days after the dose is received.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 30, 2018</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 concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC from time 0 to last quantifiable concentration</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum observed concentration</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum observed concentration</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent terminal elimination half-life</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent total clearance</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC[0-inf] plasma tucatinib/total radioactivity ratio</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>AUC[0-inf] of plasma tucatinib relative to AUC[0-inf] of plasma total radioactivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC[0-inf] blood/plasma ratio</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>AUC[0-inf] of whole blood total radioactivity to AUC[0-inf] of plasma total radioactivity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount excreted in urine (Aeu)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Aeu</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage excreted in urine (Feu)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome endpoint of tucatinib and total radioactivity derived from urine collections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Feu</measure>
    <time_frame>Up 14 days</time_frame>
    <description>PK outcome endpoint of tucatinib and total radioactivity derived from urine collections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal clearance</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome endpoint of tucatinib derived from urine collections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount excreted in feces [Aef]</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome endpoint of total radioactivity derived from feces collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Aef</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome endpoint of total radioactivity derived from feces collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage excreted in feces [Fef]</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome endpoint of total radioactivity derived from feces collection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative Fef</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PK outcome endpoint of total radioactivity derived from feces collection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relative abundance of tucatinib and its metabolites eliminated in urine and feces</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative abundance of tucatinib and its metabolites in plasma</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Tucatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tucatinib</intervention_name>
    <description>Single dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity</description>
    <arm_group_label>Tucatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In good health, determined by no clinically significant findings from medical history,&#xD;
             physical examination, 12-lead ECG, vital signs measurements, or lab evaluations&#xD;
&#xD;
          -  Body mass index (BMI) between 18 and 32 kg/m²&#xD;
&#xD;
          -  Weight between 50 and 100 kg&#xD;
&#xD;
          -  Females must be of non-childbearing potential&#xD;
&#xD;
          -  Males must agree to use contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any metabolic, allergic, dermatological, hepatic, renal, hematological,&#xD;
             pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or&#xD;
             psychiatric disorder&#xD;
&#xD;
          -  Any condition affecting drug absorption&#xD;
&#xD;
          -  History of hypersensitivity or allergy to any drug compound, food, or other substance&#xD;
&#xD;
          -  History of alcoholism or drug/chemical abuse within 2 years&#xD;
&#xD;
          -  Use of prescription products within 28 days prior to check in&#xD;
&#xD;
          -  Use of tobacco- or nicotine-containing products within 3 months prior to check in&#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>Alex Vo, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cascadian Therapeutics Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</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>Tucatinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03758339
org study id: ONT-380-008
nct id: NCT03758339
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib
      while it is still in the body. Healthy participants will get one dose of tucatinib by mouth.
      Patients will be monitored for 8-14 days after they take the dose of tucatinib.
This study will examine the absorption, metabolism, and excretion of tucatinib in healthy
      individuals. Participants will receive one oral dose of tucatinib and will be followed for
      8-14 days after the dose is received.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the concentration-time curve (AUC) from time 0 to infinity (AUC[0-inf])
time frame: Up to 14 days
description: PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
measure: AUC from time 0 to last quantifiable concentration
time frame: Up to 14 days
description: PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
measure: Maximum observed concentration
time frame: Up to 14 days
description: PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
measure: Time of maximum observed concentration
time frame: Up to 14 days
description: PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
measure: Apparent terminal elimination half-life
time frame: Up to 14 days
description: PK outcome parameter for tucatinib, ONT-993, and total radioactivity derived from the whole blood and plasma concentration-time profiles
measure: Apparent total clearance
time frame: Up to 14 days
description: PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
measure: Apparent volume of distribution
time frame: Up to 14 days
description: PK outcome parameter for tucatinib derived from the whole blood and plasma concentration-time profiles
measure: AUC[0-inf] plasma tucatinib/total radioactivity ratio
time frame: Up to 14 days
description: AUC[0-inf] of plasma tucatinib relative to AUC[0-inf] of plasma total radioactivity
measure: AUC[0-inf] blood/plasma ratio
time frame: Up to 14 days
description: AUC[0-inf] of whole blood total radioactivity to AUC[0-inf] of plasma total radioactivity
measure: Amount excreted in urine (Aeu)
time frame: Up to 14 days
description: PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
measure: Cumulative Aeu
time frame: Up to 14 days
description: PK outcome endpoint of tucatinib, ONT-993, and total radioactivity derived from urine collections
measure: Percentage excreted in urine (Feu)
time frame: Up to 14 days
description: PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
measure: Cumulative Feu
time frame: Up 14 days
description: PK outcome endpoint of tucatinib and total radioactivity derived from urine collections
measure: Renal clearance
time frame: Up to 14 days
description: PK outcome endpoint of tucatinib derived from urine collections
measure: Amount excreted in feces [Aef]
time frame: Up to 14 days
description: PK outcome endpoint of total radioactivity derived from feces collection
measure: Cumulative Aef
time frame: Up to 14 days
description: PK outcome endpoint of total radioactivity derived from feces collection
measure: Percentage excreted in feces [Fef]
time frame: Up to 14 days
description: PK outcome endpoint of total radioactivity derived from feces collection
measure: Cumulative Fef
time frame: Up to 14 days
description: PK outcome endpoint of total radioactivity derived from feces collection
measure: Relative abundance of tucatinib and its metabolites eliminated in urine and feces
time frame: Up to 14 days
measure: Relative abundance of tucatinib and its metabolites in plasma
time frame: Up to 14 days
measure: Incidence of adverse events (AEs)
time frame: Up to 14 days
arm group label: Tucatinib
arm group type: Experimental
intervention type: Drug
intervention name: tucatinib
description: Single dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity
arm group label: Tucatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alex Vo, PhD
role: Study Director
affiliation: Cascadian Therapeutics Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tucatinib
sharing ipd: No