<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/NCT03811834</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-788-1002</org_study_id>
    <secondary_id>U1111-1223-7593</secondary_id>
    <nct_id>NCT03811834</nct_id>
  </id_info>
  <brief_title>A Study to Assess Absolute Bioavailability (ABA) of Mobocertinib (TAK-788) and to Characterize Mass Balance, Pharmacokinetics (PK), Metabolism, and Excretion of Carbon-14 ([14C])-Mobocertinib in Male Healthy Participants</brief_title>
  <official_title>A Phase 1 Study to Assess Absolute Bioavailability of TAK-788 and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]-TAK-788 in Male Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Millennium Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</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 determine:&#xD;
&#xD;
      Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of&#xD;
      50 microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-mobocertinib and single oral&#xD;
      administration of 160 milligram (mg) mobocertinib.&#xD;
&#xD;
      Period 2 (absorption, distribution, metabolism, and elimination [ADME]): the mass balance and&#xD;
      metabolic profile of mobocertinib in plasma, urine, and feces, to characterize the PK of&#xD;
      mobocertinib and its metabolites (AP32960 and AP32914) in plasma, whole blood, and urine, and&#xD;
      total radioactivity concentration equivalents in plasma and whole blood following a single&#xD;
      oral administration of 160 mg (approximately 100 mcCi) [14C]-mobocertinib solution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called mobocertinib. The study will determine ABA of&#xD;
      mobocertinib following single microdose of 50 mcg [14C]-mobocertinib and single oral&#xD;
      administration of 160 mg mobocertinib and will assess the mass balance and metabolic profile&#xD;
      of mobocertinib in plasma, urine, and feces following a single oral administration of 160 mg&#xD;
      [14C]-mobocertinib solution, and will characterize the PK of mobocertinib and its metabolites&#xD;
      in plasma, whole blood, and urine, and total radioactivity concentration equivalents in&#xD;
      plasma and whole blood following a single dose of 160 mg [14C]-mobocertinib.&#xD;
&#xD;
      The study will enroll approximately 6 participants. The study is designed to consist of 2&#xD;
      periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1, all&#xD;
      participants will receive single unlabeled oral 160 mg dose of mobocertinib as capsules. At&#xD;
      3.75 hours post oral dosing, participants will receive 15-minute intravenous infusion of a&#xD;
      microdose of 50 mcg (approximately 2mcCi) [14C]-mobocertinib. In Period 2, participants will&#xD;
      receive single dose of 160 mg (approximately 100 mcCi) [14C]-mobocertinib as an oral&#xD;
      solution.&#xD;
&#xD;
      This single center trial will be conducted in the United States. The overall time to&#xD;
      participate in this study is approximately 65 days including screening period. Participants&#xD;
      will be contacted approximately 30 days after the last dose of study drug for a follow-up&#xD;
      assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">March 11, 2019</completion_date>
  <primary_completion_date type="Actual">March 11, 2019</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Period 1: Percent Absolute Oral Bioavailability (%F) for Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
    <description>Absolute bioavailability (F), defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. Percent Absolute Oral Bioavailability (%F) was calculated as dose of [14C]-mobocertinib intravenous in mg*AUC∞ of mobocertinib (oral)/dose of mobocertinib (oral)* AUC∞ of [14C]-mobocertinib (intravenous)*100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Urine Relative to the Administered Radioactive Dose</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Feces Relative to the Administered Radioactive Dose</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2: Amount of Total Radioactivity Excreted in Urine (Ae[UR])</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2: Amount of Total Radioactivity Excreted in Feces (Ae[Fe])</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Urine for Mobocertinib</measure>
    <time_frame>Day 1: Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Feces for Mobocertinib</measure>
    <time_frame>Day 1: at Pre-dose, 0-24 hours (hrs), 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs; 240-264 hrs, 264-288 hrs, 288-312 hrs, 213-408 hrs and 408-432 hrs</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, Cmax: Maximum Observed Plasma and Whole Blood Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914)</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2: t(1/2): Terminal Disposition Phase Half-life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma and Whole Blood</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUC∞: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914)</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)</measure>
    <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUCt: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time t for Mobocertinib and Its Metabolites (AP32960 and AP32914)</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, Cmax: Maximum Observed Plasma Radioactivity Concentration Equivalents for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, Cmax: Maximum Observed Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) Equivalents for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUC∞: Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUC∞: Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUClast: Area Under the Plasma Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUClast: Area Under the Whole Blood Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]- Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUCt : Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, AUCt : Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, Aet1-t2: Amount of Unchanged Drug Excreted in the Urine in Each Collection Interval From t1 to t2 for Mobocertinib and Its Metabolites (AP32960 and AP32914)</measure>
    <time_frame>Day 1: at Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs and 216-240 hrs post dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, CLR: Renal Clearance for Mobocertinib and Its Metabolites (AP32960 and AP32914)</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Period 2, Percentage Change of [14C]-Radioactivity in Whole Blood Relative to Plasma Over the Time for [14C]-Mobocertinib, (Whole Blood : Plasma Partitioning Ratio)</measure>
    <time_frame>At 0.5 hours (hrs), 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 72 hrs, 96 hrs, 120 hrs, 144 hrs, 168 hrs, 192 hrs, 216 hrs and 240 hrs post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Period 1, Ceoi: Plasma Concentration at the End of Infusion for [14C]-Mobocertinib, and Its Metabolites ([14C]-AP32960 and [14C]-AP32914)</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, Cmax: Maximum Observed Plasma Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral, and [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
    <description>Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period 1, t(1/2):Terminal Disposition Phase Half-Life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma After Oral, and [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) in Plasma After Intravenous Administration</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
    <description>Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Laboratory Values</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 microcurie [mcCi]), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mobocertinib</intervention_name>
    <description>Mobocertinib capsule, [14C]-Mobocertinib intravenous infusion, [14C]-Mobocertinib oral solution.</description>
    <arm_group_label>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg</arm_group_label>
    <other_name>TAK-788</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Continuous non smoker who has not used nicotine containing products for at least 20&#xD;
             years prior to the first dosing and throughout the study, based on subject&#xD;
             self-reporting.&#xD;
&#xD;
          2. Body mass index greater than or equal to (&gt;=)18 and less than (˂) 30.0 kilogram per&#xD;
             square meter (kg/m^2) at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Is mentally or legally incapacitated or has significant emotional problems at the time&#xD;
             of the screening visit or expected during the conduct of the study.&#xD;
&#xD;
          2. Has history or presence of alcoholism or drug abuse within the past 2 years prior to&#xD;
             the first dosing.&#xD;
&#xD;
          3. Has positive urine drug or alcohol results at screening or first check in.&#xD;
&#xD;
          4. Estimated creatinine clearance &lt; 80 milliliter per minute (mL/min) at screening.&#xD;
&#xD;
          5. Has tattoo(s) or scarring at or near the site of intravenous (IV) infusion or any&#xD;
             other condition which may interfere with infusion site examination, in the opinion of&#xD;
             the investigator.&#xD;
&#xD;
          6. Has infrequent bowel movements (less than approximately once per day) within 30 days&#xD;
             prior to first dosing.&#xD;
&#xD;
          7. Has recent history of abnormal bowel movements, such as diarrhea, loose stools, or&#xD;
             constipation, within 2 weeks of first dosing.&#xD;
&#xD;
          8. Has received radiolabeled substances or has been exposed to radiation sources within&#xD;
             12 months of first dosing or is likely to receive radiation exposure or radioisotopes&#xD;
             within 12 months of first dosing such that participation in this study would increase&#xD;
             their total exposure beyond the recommended levels considered safe (that is., weighted&#xD;
             annual limit recommended by the Commission on Radiological Protection [ICRP] of 3000&#xD;
             millirem).&#xD;
&#xD;
          9. Donation of blood or significant blood loss within 56 days prior to the first dosing.&#xD;
&#xD;
         10. Plasma donation within 7 days prior to the first dosing.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Millennium Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <results_first_submitted>March 10, 2021</results_first_submitted>
  <results_first_submitted_qc>July 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 30, 2021</results_first_posted>
  <last_update_submitted>July 9, 2021</last_update_submitted>
  <last_update_submitted_qc>July 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03811834/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03811834/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 1 investigative site in the United States from 22 January 2019 to 11 March 2019.</recruitment_details>
      <pre_assignment_details>Healthy male participants were enrolled in this 2-period study to receive mobocertinib 160 milligram (mg), capsules followed by carbon-14 [14C]-mobocertinib 50 microgram (mcg), infusion in Period 1 (Absolute Bioavailability [ABA]) and [14C]-mobocertinib 160 mg, solution in Period 2 (Absorption, Distribution, Metabolism, and Elimination [ADME]).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg</title>
          <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 microcurie [mcCi]), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 ( 7 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Washout Period (9 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2 (10 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety set included all participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg +[14C]-Mobocertinib 160 mg</title>
          <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.6" spread="12.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilogram (Kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83.74" spread="6.141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="175.9" spread="4.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI)</title>
          <units>kilogram per square meter (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.079" spread="1.6520"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Period 1: Percent Absolute Oral Bioavailability (%F) for Mobocertinib</title>
        <description>Absolute bioavailability (F), defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. Percent Absolute Oral Bioavailability (%F) was calculated as dose of [14C]-mobocertinib intravenous in mg*AUC∞ of mobocertinib (oral)/dose of mobocertinib (oral)* AUC∞ of [14C]-mobocertinib (intravenous)*100.</description>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This outcome measure (OM) was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1: Percent Absolute Oral Bioavailability (%F) for Mobocertinib</title>
          <description>Absolute bioavailability (F), defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. Percent Absolute Oral Bioavailability (%F) was calculated as dose of [14C]-mobocertinib intravenous in mg*AUC∞ of mobocertinib (oral)/dose of mobocertinib (oral)* AUC∞ of [14C]-mobocertinib (intravenous)*100.</description>
          <population>The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This outcome measure (OM) was planned to be assessed only in Period 1.</population>
          <units>percentage bioavailability</units>
          <param>Geometric Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.7" lower_limit="22.4" upper_limit="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Urine Relative to the Administered Radioactive Dose</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Urine Relative to the Administered Radioactive Dose</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>percentage of radioactive dose</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Feces Relative to the Administered Radioactive Dose</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Feces Relative to the Administered Radioactive Dose</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>percentage of radioactive dose</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.0" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2: Amount of Total Radioactivity Excreted in Urine (Ae[UR])</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2: Amount of Total Radioactivity Excreted in Urine (Ae[UR])</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>milligram equivalent (mg eq)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.777" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2: Amount of Total Radioactivity Excreted in Feces (Ae[Fe])</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2: Amount of Total Radioactivity Excreted in Feces (Ae[Fe])</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>mg eq</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123.1" spread="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Urine for Mobocertinib</title>
        <time_frame>Day 1: Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Urine for Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.</population>
          <units>percentage of radioactive dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0-12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.061" spread="0.22924"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12-24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7462" spread="0.15716"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7364" spread="0.12118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3443" spread="0.051037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72-96 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2173" spread="0.040842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96-120 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1425" spread="0.027883"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120-144 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1050" spread="0.021753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144-168 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07582" spread="0.041180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>168-192 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07517" spread="0.012835"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>192-216 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05243" spread="0.029772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>216-240 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05137" spread="0.029359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Feces for Mobocertinib</title>
        <time_frame>Day 1: at Pre-dose, 0-24 hours (hrs), 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs; 240-264 hrs, 264-288 hrs, 288-312 hrs, 213-408 hrs and 408-432 hrs</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Feces for Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.</population>
          <units>percentage of radioactive dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0-24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.13" spread="16.772"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.78" spread="19.584"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.10" spread="21.089"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72-96 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.214" spread="5.3488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>96-120 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.066" spread="2.8311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120-144 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.638" spread="1.8080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>144-168 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.756" spread="3.3943"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>168-192 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9919" spread="0.83406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>192-216 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.069" spread="1.0034"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>216-240 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.695" spread="1.1513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>240-264 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1056" spread="0.14927"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>264-288 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2216" spread="0.31341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>288-312 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7632" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>312-408 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3107" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>408-432 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1143" spread="NA">Standard deviation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, Cmax: Maximum Observed Plasma and Whole Blood Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, Cmax: Maximum Observed Plasma and Whole Blood Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.0" spread="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7" spread="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" spread="34.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.5" spread="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.05" spread="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" lower_limit="3.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="3.00" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" lower_limit="3.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.01" lower_limit="2.01" upper_limit="6.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.01" lower_limit="3.02" upper_limit="5.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.01" lower_limit="4.01" upper_limit="6.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2: t(1/2): Terminal Disposition Phase Half-life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma and Whole Blood</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2: t(1/2): Terminal Disposition Phase Half-life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma and Whole Blood</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.5" spread="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5" spread="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.9" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUC∞: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUC∞: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram*hour per milliliter (ng*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="956" spread="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="486" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.4" spread="39.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="729" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556" spread="20.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4" spread="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
        <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="945" spread="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="471" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" spread="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="718" spread="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="543" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7" spread="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUCt: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time t for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUCt: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time t for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="944.9" spread="39.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="471.1" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.61" spread="45.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="717.7" spread="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="542.8" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood: AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.74" spread="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, Cmax: Maximum Observed Plasma Radioactivity Concentration Equivalents for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, Cmax: Maximum Observed Plasma Radioactivity Concentration Equivalents for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram equivalent/milliliter(ng eq/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1250" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, Cmax: Maximum Observed Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, Cmax: Maximum Observed Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram equivalent/ gram (ng eq/g)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="725" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) Equivalents for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-Mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) Equivalents for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="8.02" upper_limit="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" lower_limit="8.01" upper_limit="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Plasma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="281" spread="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Whole Blood</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="301" spread="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUC∞: Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUC∞: Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram equivalent*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="556000" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUC∞: Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUC∞: Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram equivalent*hour per gram</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="325000" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUClast: Area Under the Plasma Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUClast: Area Under the Plasma Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram equivalent*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="230300" spread="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUClast: Area Under the Whole Blood Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]- Mobocertinib</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUClast: Area Under the Whole Blood Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]- Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram equivalent*hour per gram</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131000" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUCt : Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUCt : Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram equivalent*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145400" spread="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, AUCt : Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, AUCt : Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>nanogram equivalent*hour per gram</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70190" spread="32.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, Aet1-t2: Amount of Unchanged Drug Excreted in the Urine in Each Collection Interval From t1 to t2 for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
        <time_frame>Day 1: at Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs and 216-240 hrs post dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, Aet1-t2: Amount of Unchanged Drug Excreted in the Urine in Each Collection Interval From t1 to t2 for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 2.</population>
          <units>mg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobocertinib: Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.001072" spread="0.0010474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 0 to 12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1917" spread="0.10878"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 12 to 24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2047" spread="0.084347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 24 to 48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1628" spread="0.050589"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 48 to 72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05069" spread="0.029114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 72 to 96 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02087" spread="0.013052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 96 to 120 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01028" spread="0.0052244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 120 to 144 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.005860" spread="0.0055472"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 144 to 168 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.002438" spread="0.0014131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 168 to 192 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0009682" spread="0.0011637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 192 to 216 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0009890" spread="0.00090295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mobocertinib: 216 to 240 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0002824" spread="0.00063158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.005308" spread="0.0045461"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 0-12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2948" spread="0.078117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 12-24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2199" spread="0.056834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 24-48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2166" spread="0.049030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 48-72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09444" spread="0.020647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 72-96 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05401" spread="0.014311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 96-120 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03017" spread="0.0070669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 120-144 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01764" spread="0.0068670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 144-168 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01082" spread="0.0028229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 168-192 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.007272" spread="0.0023649"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 192-216 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.005427" spread="0.0021935"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960: 216-240 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.004235" spread="0.0016891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: Pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 0-12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08336" spread="0.022896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 12-24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06029" spread="0.015305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 24-48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04953" spread="0.021338"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 48-72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01543" spread="0.0068257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 72-96 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.005859" spread="0.0040117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 96-120 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.002477" spread="0.0016606"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 120-144 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0008353" spread="0.0010134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 144-168 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0001780" spread="0.00043613"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 168-192 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 192-216 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914: 216-240 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, CLR: Renal Clearance for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, CLR: Renal Clearance for Mobocertinib and Its Metabolites (AP32960 and AP32914)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 2.</population>
          <units>liter per hour ( L/h)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.657" spread="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.95" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.85" spread="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Period 2, Percentage Change of [14C]-Radioactivity in Whole Blood Relative to Plasma Over the Time for [14C]-Mobocertinib, (Whole Blood : Plasma Partitioning Ratio)</title>
        <time_frame>At 0.5 hours (hrs), 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 72 hrs, 96 hrs, 120 hrs, 144 hrs, 168 hrs, 192 hrs, 216 hrs and 240 hrs post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. Here, '0' in the number analyzed field signifies that no participants were evaluable at specified time points. This OM was planned to be assessed only in Period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 2, Percentage Change of [14C]-Radioactivity in Whole Blood Relative to Plasma Over the Time for [14C]-Mobocertinib, (Whole Blood : Plasma Partitioning Ratio)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. Here, '0' in the number analyzed field signifies that no participants were evaluable at specified time points. This OM was planned to be assessed only in Period 2.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At 0.5 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.022" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 1 hour</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9851" spread="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 2 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9055" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 3 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8403" spread="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 4 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8221" spread="23.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 5 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8545" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 6 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7647" spread="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 8 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7634" spread="20.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 12 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7573" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8139" spread="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 36 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7028" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 48 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7113" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 72 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6453" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 96 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6164" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 120 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6260" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 144 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5946" spread="NA">Geometric coefficient of variation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At 168 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>At 192 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>At 216 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>At 240 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, Ceoi: Plasma Concentration at the End of Infusion for [14C]-Mobocertinib, and Its Metabolites ([14C]-AP32960 and [14C]-AP32914)</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously over 15 minutes, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, Ceoi: Plasma Concentration at the End of Infusion for [14C]-Mobocertinib, and Its Metabolites ([14C]-AP32960 and [14C]-AP32914)</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
          <units>picograms per milliliter (pg /mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[14C]-Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.3" spread="46.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.842" spread="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.432" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.7" spread="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.29" spread="21.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.086" spread="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, Cmax: Maximum Observed Plasma Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, Cmax: Maximum Observed Plasma Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
          <units>pg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[14C]-mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148" spread="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]-AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.631" spread="76.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]-AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.772" spread="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral, and [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
        <description>Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration.</description>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral, and [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
          <description>Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration.</description>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.00" lower_limit="4.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.502" lower_limit="4.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.000" lower_limit="4.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]-mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" lower_limit="0.26" upper_limit="1.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.257" lower_limit="2.25" upper_limit="8.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.26" lower_limit="2.26" upper_limit="2.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1050" spread="64.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="478.2" spread="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.02" spread="53.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.</population>
          <units>picogram*hour/ milliliter (pg*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[14C]-Mobocertinib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="680" spread="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32960</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187.8" spread="60.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32914</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.71" spread="NA">Geometric coefficient of variation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. This OM was planned to be assessed only in Period 1.</population>
          <units>ng*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobocertinib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1032" spread="65.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="461.2" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.92" spread="53.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.</population>
          <units>pg*hr/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[14C]-Mobocertinib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="617.9" spread="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]-AP32960</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.1" spread="63.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]-AP32914</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.52" spread="113.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.</population>
          <units>picogram*hour per milliliter (pg*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[14C]-Mobocertinib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="617.9" spread="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32960</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133.1" spread="63.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32914</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.52" spread="113.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Period 1, t(1/2):Terminal Disposition Phase Half-Life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma After Oral, and [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) in Plasma After Intravenous Administration</title>
        <description>Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration.</description>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose</time_frame>
        <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Period 1, t(1/2):Terminal Disposition Phase Half-Life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma After Oral, and [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) in Plasma After Intravenous Administration</title>
          <description>Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration.</description>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here number analyzed &quot;n&quot; are the participants who were evaluable for the outcome measure at given timepoints. This OM was planned to be assessed only in Period 1.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mobocertinib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32960</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.077" spread="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.545" spread="37.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]-Mobocertinib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" spread="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32960</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.317" spread="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[14C]- AP32914</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.900" spread="NA">Geometric coefficient of variation could not be calculated because single participant was analyzed.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
        <time_frame>Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)</time_frame>
        <population>The safety set included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)</title>
          <population>The safety set included all participants who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings</title>
        <time_frame>Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)</time_frame>
        <population>The safety set included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings</title>
          <population>The safety set included all participants who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</title>
        <time_frame>Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)</time_frame>
        <population>The safety set included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Vital Signs</title>
          <population>The safety set included all participants who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Laboratory Values</title>
        <time_frame>Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)</time_frame>
        <population>The safety set included all participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
            <description>Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
          </group>
          <group group_id="O2">
            <title>[14C]-Mobocertinib 160 mg</title>
            <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Laboratory Values</title>
          <population>The safety set included all participants who received at least one dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events are adverse events that started after the first dose of study drug until 30 days after last dose of study drug in Period 2 (up to Day 41)</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg</title>
          <description>Mobocertinib160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 mcCi), infusion, intravenously, once on Day 1 of Period 1.</description>
        </group>
        <group group_id="E2">
          <title>[14C]-Mobocertinib 160 mg</title>
          <description>[14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cow's milk intolerance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03811834
org study id: TAK-788-1002
secondary id: U1111-1223-7593
nct id: NCT03811834
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine:

      Period 1 (ABA): ABA of mobocertinib following single microdose intravenous administration of
      50 microgram (mcg) (approximately 2 microcurie [mcCi]) [14 C]-]-mobocertinib and single oral
      administration of 160 milligram (mg) mobocertinib.

      Period 2 (absorption, distribution, metabolism, and elimination [ADME]): the mass balance and
      metabolic profile of mobocertinib in plasma, urine, and feces, to characterize the PK of
      mobocertinib and its metabolites (AP32960 and AP32914) in plasma, whole blood, and urine, and
      total radioactivity concentration equivalents in plasma and whole blood following a single
      oral administration of 160 mg (approximately 100 mcCi) [14C]-mobocertinib solution.
The drug being tested in this study is called mobocertinib. The study will determine ABA of
      mobocertinib following single microdose of 50 mcg [14C]-mobocertinib and single oral
      administration of 160 mg mobocertinib and will assess the mass balance and metabolic profile
      of mobocertinib in plasma, urine, and feces following a single oral administration of 160 mg
      [14C]-mobocertinib solution, and will characterize the PK of mobocertinib and its metabolites
      in plasma, whole blood, and urine, and total radioactivity concentration equivalents in
      plasma and whole blood following a single dose of 160 mg [14C]-mobocertinib.

      The study will enroll approximately 6 participants. The study is designed to consist of 2
      periods: Period 1 (ABA study period) and Period 2 (ADME study period). In Period 1, all
      participants will receive single unlabeled oral 160 mg dose of mobocertinib as capsules. At
      3.75 hours post oral dosing, participants will receive 15-minute intravenous infusion of a
      microdose of 50 mcg (approximately 2mcCi) [14C]-mobocertinib. In Period 2, participants will
      receive single dose of 160 mg (approximately 100 mcCi) [14C]-mobocertinib as an oral
      solution.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 65 days including screening period. Participants
      will be contacted approximately 30 days after the last dose of study drug for a follow-up
      assessment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Period 1: Percent Absolute Oral Bioavailability (%F) for Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
description: Absolute bioavailability (F), defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. Percent Absolute Oral Bioavailability (%F) was calculated as dose of [14C]-mobocertinib intravenous in mg*AUC∞ of mobocertinib (oral)/dose of mobocertinib (oral)* AUC∞ of [14C]-mobocertinib (intravenous)*100.
measure: Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Urine Relative to the Administered Radioactive Dose
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2: Percentage of Total Radioactivity (Cum%Dose) Recovered in Feces Relative to the Administered Radioactive Dose
time frame: Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose
measure: Period 2: Amount of Total Radioactivity Excreted in Urine (Ae[UR])
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2: Amount of Total Radioactivity Excreted in Feces (Ae[Fe])
time frame: Day 1 pre-dose and at multiple time points (up to 432 hours) post-dose
measure: Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Urine for Mobocertinib
time frame: Day 1: Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs post-dose
measure: Period 2: Percentage of Administered Radioactive Dose (%Dose) Excreted in Feces for Mobocertinib
time frame: Day 1: at Pre-dose, 0-24 hours (hrs), 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs, 216-240 hrs; 240-264 hrs, 264-288 hrs, 288-312 hrs, 213-408 hrs and 408-432 hrs
measure: Period 2, Cmax: Maximum Observed Plasma and Whole Blood Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914)
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2: t(1/2): Terminal Disposition Phase Half-life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma and Whole Blood
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUC∞: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914)
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUClast: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914)
time frame: Day 1 pre-dose at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUCt: Area Under the Plasma and Whole Blood Concentration-time Curve From Time 0 to Time t for Mobocertinib and Its Metabolites (AP32960 and AP32914)
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, Cmax: Maximum Observed Plasma Radioactivity Concentration Equivalents for [14C]-Mobocertinib
time frame: Day 1 pre-dose at multiple time points (up to 240 hours) post-dose
measure: Period 2, Cmax: Maximum Observed Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib
time frame: Day 1 pre-dose at multiple time points (up to 240 hours) post-dose
measure: Period 2, Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) Equivalents for [14C]-Mobocertinib
time frame: Day 1 pre-dose at multiple time points (up to 240 hours) post-dose
measure: Period 2, t(1/2z): Terminal Disposition Phase Half-life of Plasma and Whole Blood Radioactivity Concentration Equivalents for [14C]-Mobocertinib
time frame: Day 1 pre-dose at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUC∞: Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUC∞: Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Infinity for [14C]-Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUClast: Area Under the Plasma Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUClast: Area Under the Whole Blood Radioactivity Concentration Equivalents -Time Curve From Time 0 to Last Quantifiable Concentration for [14C]- Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUCt : Area Under the Plasma Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, AUCt : Area Under the Whole Blood Radioactivity Concentration Equivalents-time Curve From Time 0 to Time t for [14C]-Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, Aet1-t2: Amount of Unchanged Drug Excreted in the Urine in Each Collection Interval From t1 to t2 for Mobocertinib and Its Metabolites (AP32960 and AP32914)
time frame: Day 1: at Pre-dose, 0-12 hours (hrs), 12-24 hrs, 24-48 hrs, 48-72 hrs, 72-96 hrs, 96-120 hrs, 120-144 hrs, 144-168 hrs, 168-192 hrs, 192-216 hrs and 216-240 hrs post dose
measure: Period 2, CLR: Renal Clearance for Mobocertinib and Its Metabolites (AP32960 and AP32914)
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Period 2, Percentage Change of [14C]-Radioactivity in Whole Blood Relative to Plasma Over the Time for [14C]-Mobocertinib, (Whole Blood : Plasma Partitioning Ratio)
time frame: At 0.5 hours (hrs), 1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 72 hrs, 96 hrs, 120 hrs, 144 hrs, 168 hrs, 192 hrs, 216 hrs and 240 hrs post-dose
measure: Period 1, Ceoi: Plasma Concentration at the End of Infusion for [14C]-Mobocertinib, and Its Metabolites ([14C]-AP32960 and [14C]-AP32914)
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
measure: Period 1, Cmax: Maximum Observed Plasma Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
measure: Period 1, Cmax: Maximum Observed Plasma Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
measure: Period 1, Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral, and [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
description: Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration.
measure: Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
measure: Period 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) After Intravenous Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
measure: Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for Mobocertinib and Its Metabolites (AP32960 and AP32914) After Oral Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
measure: Period 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
measure: Period 1, AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for [14C]-Mobocertinib and Its Metabolites ([14C]-AP32960 and [14C]-AP32914) After Intravenous Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
measure: Period 1, t(1/2):Terminal Disposition Phase Half-Life of Mobocertinib and Its Metabolites (AP32960 and AP32914) in Plasma After Oral, and [14C]-Mobocertinib and Its Metabolites ( [14C]-AP32960 and [14C]-AP32914) in Plasma After Intravenous Administration
time frame: Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
description: Data for mobocertinib and its metabolites (AP32960 and AP32914) is reported following the oral administration, and data for [14C]-mobocertinib and its metabolites ([14C]-AP32960 and [14C]-AP32914) is reported following intravenous administration.
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
time frame: Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)
measure: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
time frame: Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
time frame: Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
time frame: Baseline up to 30 days after last dose of study drug in Period 2 (Day 41)
arm group label: Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg
arm group type: Experimental
description: Mobocertinib 160 mg, capsule, orally, once under fasted state, followed by [14C]-mobocertinib 50 mcg (approximately 2 microcurie [mcCi]), infusion, intravenously, once on Day 1 of Period 1, further followed by a washout period of 9 days, followed by [14C]-mobocertinib 160 mg (approximately 100 mcCi), solution, orally, once under fasted state on Day 1 of Period 2.
intervention type: Drug
intervention name: Mobocertinib
description: Mobocertinib capsule, [14C]-Mobocertinib intravenous infusion, [14C]-Mobocertinib oral solution.
arm group label: Mobocertinib 160 mg and [14C]-Mobocertinib 50 mcg + [14C]-Mobocertinib 160 mg
other name: TAK-788
criteria: 
gender: Male
gender based: Yes
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Millennium Pharmaceuticals, Inc.
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 