<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/NCT04441255</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-788-1005</org_study_id>
    <secondary_id>CA24171</secondary_id>
    <nct_id>NCT04441255</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics (PK) in Healthy Adult Participants</brief_title>
  <official_title>A Phase 1, Randomized, 2-Period, 2-Sequence, Crossover Study to Evaluate the Effect of High-Fat Meal on TAK-788 Pharmacokinetics in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</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 characterize the effect of a high-fat meal on the PK of&#xD;
      TAK-788 administered in healthy participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TAK-788. The study will characterize the effect&#xD;
      of a high-fat meal on the PK of TAK-788 administered in healthy participants.&#xD;
&#xD;
      The study will enroll approximately 14 participants. Participants will be randomly assigned&#xD;
      (by chance, like flipping a coin) to one of the two treatment sequence&#xD;
&#xD;
        -  TAK-788 160 mg Fasted (Reference) in Period 1 + TAK-788 160 mg Fed (Test) in Period 2&#xD;
&#xD;
        -  TAK-788 160 mg Fed (Test) in Period 1 + TAK-788 160 mg Fasted (Reference) in Period 2&#xD;
&#xD;
      All participants will be asked to take capsules of assigned TAK-788 on Day 1 of each period.&#xD;
&#xD;
      This single-center trial will be conducted in the United States. The overall time to&#xD;
      participate in this study is 61 days. Participants will be contacted by telephone for 30 days&#xD;
      after the last dose of study drug for a follow-up assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 10, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for 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>Cmax: Maximum Observed Plasma Concentration for 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>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for 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>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib</measure>
    <time_frame>Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>TAK-788 160 mg Fasted + TAK-788 160 mg Fed</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-788 160 milligram (mg), capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-788 160 mg Fed + TAK-788 160 mg Fasted</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-788 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-788</intervention_name>
    <description>TAK-788 Capsule.</description>
    <arm_group_label>TAK-788 160 mg Fasted + TAK-788 160 mg Fed</arm_group_label>
    <arm_group_label>TAK-788 160 mg Fed + TAK-788 160 mg Fasted</arm_group_label>
    <other_name>AP32788</other_name>
    <other_name>Mobocertinib</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 participant&#xD;
             self-reporting.&#xD;
&#xD;
          2. Body mass index (BMI) greater than or equal to (&gt;=) 18.5 and less than or equal to&#xD;
             (&lt;=) 30.0 kilogram per square meter (kg/m^2), at screening.&#xD;
&#xD;
          3. Medically healthy with no clinically significant medical history, physical&#xD;
             examination, laboratory profiles, vital signs, or electrocardiogram (ECGs), as deemed&#xD;
             by the Investigator or designee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of any illness (including hyperlipidemia and diabetes since high fat meal is&#xD;
             required) that, in the opinion of the Investigator or designee, might confound the&#xD;
             results of the study or poses an additional risk to the participant by their&#xD;
             participation in the study.&#xD;
&#xD;
          2. History or presence of alcoholism or drug abuse within the past 2 years prior to the&#xD;
             first dosing.&#xD;
&#xD;
          3. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs&#xD;
             or related compounds.&#xD;
&#xD;
          4. History or presence of any previous lung disease and/or current lung infection.&#xD;
&#xD;
          5. Positive urine drug or alcohol results at screening or first check-in.&#xD;
&#xD;
          6. Positive results at screening for Human immunodeficiency virus (HIV), Hepatitis B&#xD;
             surface antigen (HBsAg), or Hepatitis C virus (HCV).&#xD;
&#xD;
          7. Positive test result for active coronavirus disease 2019 (COVID-19).&#xD;
&#xD;
          8. Seated blood pressure is less than (&lt;) 90/40 millimeter of mercury of mercury (mmHg)&#xD;
             or greater than 140/90 mmHg at screening.&#xD;
&#xD;
          9. Seated heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at&#xD;
             screening.&#xD;
&#xD;
         10. QT interval corrected for heart rate using Fridericia's formula (QTcF) interval is&#xD;
             greater than (&gt;) 460 millisecond (msec) (males) or &gt;470 msec (females) or ECG findings&#xD;
             are deemed abnormal with clinical significance by the Investigator or designee at&#xD;
             screening.&#xD;
&#xD;
         11. Creatinine clearance &lt;90 milliliter per minute (mL/min) at screening (calculated using&#xD;
             the Cockcroft-Gault formula).&#xD;
&#xD;
         12. Unable to refrain from or anticipates the use of:&#xD;
&#xD;
             o Any drug, including prescription and non-prescription medications, herbal remedies,&#xD;
             or vitamin supplements within 14 days prior to the first dosing and throughout the&#xD;
             study. Medication listed as part of acceptable birth control methods will be allowed.&#xD;
             Thyroid hormone replacement medication may be permitted if the participant has been on&#xD;
             the same stable dose for the immediate 3 months prior to the first dosing.&#xD;
&#xD;
             Acetaminophen (up to 2 gram per 24 hour period) may be permitted during the study,&#xD;
             only after initial dosing, if necessary, to treat adverse events (AEs).&#xD;
&#xD;
             o Any drugs known to be inhibitors or inducers of Cytochrome P450 (CYP3A) enzymes&#xD;
             and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the&#xD;
             first dosing and throughout the study.&#xD;
&#xD;
         13. Has been on a diet incompatible with the on-study diet, in the opinion of the&#xD;
             Investigator or designee, within the 30 days prior to the first dosing and throughout&#xD;
             the study.&#xD;
&#xD;
         14. Donation of blood or significant blood loss within 56 days prior to the first dosing.&#xD;
&#xD;
         15. Plasma donation within 7 days prior to the first dosing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</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>August 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <results_first_submitted>August 10, 2021</results_first_submitted>
  <results_first_submitted_qc>August 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 5, 2021</results_first_posted>
  <last_update_submitted>August 10, 2021</last_update_submitted>
  <last_update_submitted_qc>August 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 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 makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.</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>June 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT04441255/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 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT04441255/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 01 July 2020 to 10 August 2020.</recruitment_details>
      <pre_assignment_details>Healthy participants were enrolled in 1 of the 2 treatment sequences of this 2-period cross-over study to receive mobocertinib (TAK-788) 160 milligram (mg), capsule, in fasted condition (Treatment A) or mobocertinib 160 mg, capsule, in fed condition (Treatment B).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mobocertinib 160 mg Fasted + Mobocertinib 160 mg Fed</title>
          <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).</description>
        </group>
        <group group_id="P2">
          <title>Mobocertinib 160 mg Fed + Mobocertinib 160 mg Fasted</title>
          <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1 (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period (10 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Period 2 (1 Day)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" 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 a study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Mobocertinib 160 mg Fasted + Mobocertinib 160 mg Fed</title>
          <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).</description>
        </group>
        <group group_id="B2">
          <title>Mobocertinib 160 mg Fed + Mobocertinib 160 mg Fasted</title>
          <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, further followed by mobocertinib 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="14"/>
          </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="34.0" spread="9.61"/>
                    <measurement group_id="B2" value="35.4" spread="9.14"/>
                    <measurement group_id="B3" value="34.7" spread="9.04"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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 group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </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="73.89" spread="11.879"/>
                    <measurement group_id="B2" value="76.70" spread="16.416"/>
                    <measurement group_id="B3" value="75.29" spread="13.843"/>
                  </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="174.3" spread="9.48"/>
                    <measurement group_id="B2" value="175.6" spread="13.50"/>
                    <measurement group_id="B3" value="174.9" spread="11.23"/>
                  </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="24.293" spread="3.0143"/>
                    <measurement group_id="B2" value="24.706" spread="3.2743"/>
                    <measurement group_id="B3" value="24.499" spread="3.0311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib</title>
        <time_frame>Day 1 pre-dose and at multiple time points (up to 240 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.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg Fasted</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
          </group>
          <group group_id="O2">
            <title>Mobocertinib 160 mg Fed</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib</title>
          <population>The pharmacokinetic (PK) set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.01" lower_limit="4.00" upper_limit="8.00"/>
                    <measurement group_id="O2" value="8.00" lower_limit="4.01" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for 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.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg Fasted</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
          </group>
          <group group_id="O2">
            <title>Mobocertinib 160 mg Fed</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.</population>
          <units>nanogram per milliliter (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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.8" spread="47.1"/>
                    <measurement group_id="O2" value="56.6" spread="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for 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.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg Fasted</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
          </group>
          <group group_id="O2">
            <title>Mobocertinib 160 mg Fed</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</description>
          </group>
        </group_list>
        <measure>
          <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1030" spread="61.1"/>
                    <measurement group_id="O2" value="1230" spread="59.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for 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.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg Fasted</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
          </group>
          <group group_id="O2">
            <title>Mobocertinib 160 mg Fed</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</description>
          </group>
        </group_list>
        <measure>
          <title>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1020" spread="61.4"/>
                    <measurement group_id="O2" value="1210" spread="60.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of 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.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg Fasted</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
          </group>
          <group group_id="O2">
            <title>Mobocertinib 160 mg Fed</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" lower_limit="4.00" upper_limit="8.02"/>
                    <measurement group_id="O2" value="8.00" lower_limit="4.01" upper_limit="8.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.01" lower_limit="4.00" upper_limit="8.02"/>
                    <measurement group_id="O2" value="8.00" lower_limit="4.01" upper_limit="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of 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.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg Fasted</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
          </group>
          <group group_id="O2">
            <title>Mobocertinib 160 mg Fed</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1" spread="22.3"/>
                    <measurement group_id="O2" value="27.7" spread="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.34" spread="31.7"/>
                    <measurement group_id="O2" value="3.73" spread="31.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of 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. Here &quot;number analyzed&quot; were participants who were evaluable for the outcome measure at given categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg Fasted</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
          </group>
          <group group_id="O2">
            <title>Mobocertinib 160 mg Fed</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</description>
          </group>
        </group_list>
        <measure>
          <title>AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. Here &quot;number analyzed&quot; were participants who were evaluable for the outcome measure at given categories.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AP32960</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="704" spread="31.3"/>
                    <measurement group_id="O2" value="731" spread="32.2"/>
                  </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="12"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.4" spread="47.4"/>
                    <measurement group_id="O2" value="89.2" spread="50.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Active Metabolites (AP32960 and AP32914) of 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.</population>
        <group_list>
          <group group_id="O1">
            <title>Mobocertinib 160 mg Fasted</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
          </group>
          <group group_id="O2">
            <title>Mobocertinib 160 mg Fed</title>
            <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</description>
          </group>
        </group_list>
        <measure>
          <title>AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib</title>
          <population>The PK set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile.</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="13"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AP32960</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="682" spread="31.9"/>
                    <measurement group_id="O2" value="709" spread="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP32914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2" spread="50.1"/>
                    <measurement group_id="O2" value="72.2" spread="53.9"/>
                  </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 42).</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 Fasted</title>
          <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fasted conditions (Treatment A).</description>
        </group>
        <group group_id="E2">
          <title>Mobocertinib 160 mg Fed</title>
          <description>Mobocertinib 160 mg, capsule, orally, once on Day 1 of either Period 1 or Period 2 under fed conditions (Treatment B).</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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="5" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pustule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
              </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>Study 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/NCT04441255
org study id: TAK-788-1005
secondary id: CA24171
nct id: NCT04441255
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to characterize the effect of a high-fat meal on the PK of
      TAK-788 administered in healthy participants.
The drug being tested in this study is called TAK-788. The study will characterize the effect
      of a high-fat meal on the PK of TAK-788 administered in healthy participants.

      The study will enroll approximately 14 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the two treatment sequence

        -  TAK-788 160 mg Fasted (Reference) in Period 1 + TAK-788 160 mg Fed (Test) in Period 2

        -  TAK-788 160 mg Fed (Test) in Period 1 + TAK-788 160 mg Fasted (Reference) in Period 2

      All participants will be asked to take capsules of assigned TAK-788 on Day 1 of each period.

      This single-center trial will be conducted in the United States. The overall time to
      participate in this study is 61 days. Participants will be contacted by telephone for 30 days
      after the last dose of study drug for a follow-up assessment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Active Metabolites (AP32960 and AP32914) of Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: Cmax: Maximum Observed Plasma Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Active Metabolites (AP32960 and AP32914) of Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
measure: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Active Metabolites (AP32960 and AP32914) of Mobocertinib
time frame: Day 1 pre-dose and at multiple time points (up to 240 hours) post-dose
arm group label: TAK-788 160 mg Fasted + TAK-788 160 mg Fed
arm group type: Experimental
description: TAK-788 160 milligram (mg), capsule, orally, once on Day 1 of Period 1 under fasted conditions (Treatment A), followed by 10 days washout period, followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Period 2 under fed conditions (Treatment B).
arm group label: TAK-788 160 mg Fed + TAK-788 160 mg Fasted
arm group type: Experimental
description: TAK-788 160 mg, capsule, orally, once on Day 1 of Period 1 under fed conditions (Treatment B), followed by 10 days washout period, followed by TAK-788 160 mg, capsule, orally, once on Day 1 of Period 2 under fasted conditions (Treatment A).
intervention type: Drug
intervention name: TAK-788
description: TAK-788 Capsule.
arm group label: TAK-788 160 mg Fasted + TAK-788 160 mg Fed
arm group label: TAK-788 160 mg Fed + TAK-788 160 mg Fasted
other name: AP32788
other name: Mobocertinib
criteria: 
gender: All
minimum age: 19 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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: 