<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/NCT04493255</url>
  </required_header>
  <id_info>
    <org_study_id>E7090-E044-002</org_study_id>
    <secondary_id>2019-004957-10</secondary_id>
    <nct_id>NCT04493255</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants</brief_title>
  <official_title>An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to determine the pharmacokinetics (PK) and excretion&#xD;
      of E7090 and its metabolites in healthy male participants. Also, to assess the safety and&#xD;
      tolerability of a single dose of E7090 in healthy male participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Actual">October 21, 2020</completion_date>
  <primary_completion_date type="Actual">October 21, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine</measure>
    <time_frame>Up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative feu: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine From 0 to tlast Hours</measure>
    <time_frame>Up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>fef: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces</measure>
    <time_frame>Up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative fef: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces From 0 to tlast Hours</measure>
    <time_frame>Up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>feu+ef: Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces)</measure>
    <time_frame>Up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative feu+ef: Cumulative Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces) From 0 to tlast Hours</measure>
    <time_frame>Up to Day 57</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites</measure>
    <time_frame>Day 1: 0-672 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites</measure>
    <time_frame>Day 1: 0-672 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for [14C]E7090, E7090 and its Metabolites</measure>
    <time_frame>Day 1: 0-24 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC(0-t): Area Under the Concentration- time Curve From Time 0 to Time of Last Quantifiable Concentration for [14C]E7090, E7090 and its Metabolites</measure>
    <time_frame>Day 1: 0-672 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]E7090, E7090 and its Metabolites</measure>
    <time_frame>Day 1: 0-672 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites</measure>
    <time_frame>Day 1: 0-672 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F: Apparent Total Body Clearance for E7090</measure>
    <time_frame>Day 1: 0-672 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vd/F: Apparent Volume of Distribution for E7090</measure>
    <time_frame>Day 1: 0-672 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>MPR AUC(0-inf): Metabolite to Parent Ratio For AUC(0-inf) of Metabolite to E7090, Corrected for Molecular Weights</measure>
    <time_frame>Day 1: 0-672 hours post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic profile of E7090: Concentration of Metabolite of E7090 in Plasma, Urine, and Feces</measure>
    <time_frame>Up to Day 57</time_frame>
    <description>Blood, urine and feces samples will be collected and analyzed to estimate the concentration of metabolite of E7090 by Liquid Chromatography/ multiple-stage Mass Spectroscopy method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline up to Day 57</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values</measure>
    <time_frame>Baseline up to Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values</measure>
    <time_frame>Baseline up to Day 29</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 Day 29</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Baseline up to Day 29</time_frame>
    <description>The C-SSRS is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is &quot;yes&quot; for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is &quot;yes&quot; for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality will be reported for this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Ophthalmic Examinations</measure>
    <time_frame>Baseline up to Day 29</time_frame>
    <description>Ophthalmic examinations includes visual acuity, funduscopy, optical coherence tomography, and slit-lamp examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Physical Examinations</measure>
    <time_frame>Baseline up to Day 29</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>E7090</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 100 microcurie (μCi) of [14C]E7090 as a single 35 milligram (mg), capsule, orally on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]E7090</intervention_name>
    <description>[14C]E7090, oral capsule.</description>
    <arm_group_label>E7090</arm_group_label>
    <other_name>E7090</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Non-smoking, healthy males, age greater than or equal to (&gt;=) 35 years and less than&#xD;
             or equal to (&lt;=) 55 years old at the time of informed consent&#xD;
&#xD;
          2. Body Mass Index (BMI) of &gt;=18 to &lt;=32 kilogram per square meter (kg/m^2) at Screening&#xD;
&#xD;
          3. Provide written informed consent&#xD;
&#xD;
          4. Willing and able to comply with all aspects of the protocol&#xD;
&#xD;
          5. History of a minimum of 1 bowel movement per day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participant has participated in any clinical research study involving a radiolabeled&#xD;
             investigational product within the 12 months prior to Day -1 (Baseline)&#xD;
&#xD;
          2. Participant has previously completed or withdrawn from this study or any other study&#xD;
             investigating E7090 or previously received E7090&#xD;
&#xD;
          3. Participant has had exposure to significant diagnostic or therapeutic radiation&#xD;
             (example: serial x-ray, computed tomography scan, barium meal) or has current&#xD;
             employment in a job requiring radiation exposure monitoring within 12 months prior to&#xD;
             Day -1&#xD;
&#xD;
          4. Participant has the following ocular disorders:&#xD;
&#xD;
               1. Any previous history or current evidence of corneal disorder&#xD;
&#xD;
               2. Any previous history or current evidence of active macular disorder (example:&#xD;
                  age-related macular degeneration, central serous chorioretinal disease)&#xD;
&#xD;
          5. Participants has a known history of clinically significant drug allergy at Screening&#xD;
             or Baseline (Day -1)&#xD;
&#xD;
          6. Participants has a known history of food allergies or significant seasonal or&#xD;
             perennial allergy&#xD;
&#xD;
          7. Participants is known to be human immunodeficiency virus positive at Screening&#xD;
&#xD;
          8. Participants has active viral hepatitis (B or C) as demonstrated by positive serology&#xD;
             at Screening&#xD;
&#xD;
          9. Participant has a poor peripheral venous access, in the opinion of the investigator&#xD;
             (or designee)&#xD;
&#xD;
         10. Participant received blood products within 2 months prior to Day -1, or donation of&#xD;
             blood within 3 months prior to Screening, donation of plasma within 2 weeks prior to&#xD;
             Screening, or donation of platelets from 6 weeks prior to Screening&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Covance Clinical Research Unit</name>
      <address>
        <city>Leeds</city>
        <zip>LS2 9LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy Participants</keyword>
  <keyword>Phase 1</keyword>
  <keyword>Pharmacokinetics</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04493255
org study id: E7090-E044-002
secondary id: 2019-004957-10
nct id: NCT04493255
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to determine the pharmacokinetics (PK) and excretion
      of E7090 and its metabolites in healthy male participants. Also, to assess the safety and
      tolerability of a single dose of E7090 in healthy male participants.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine
time frame: Up to Day 57
measure: Cumulative feu: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine From 0 to tlast Hours
time frame: Up to Day 57
measure: fef: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces
time frame: Up to Day 57
measure: Cumulative fef: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces From 0 to tlast Hours
time frame: Up to Day 57
measure: feu+ef: Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces)
time frame: Up to Day 57
measure: Cumulative feu+ef: Cumulative Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces) From 0 to tlast Hours
time frame: Up to Day 57
measure: Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites
time frame: Day 1: 0-672 hours post-dose
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites
time frame: Day 1: 0-672 hours post-dose
measure: AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for [14C]E7090, E7090 and its Metabolites
time frame: Day 1: 0-24 hours post-dose
measure: AUC(0-t): Area Under the Concentration- time Curve From Time 0 to Time of Last Quantifiable Concentration for [14C]E7090, E7090 and its Metabolites
time frame: Day 1: 0-672 hours post-dose
measure: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]E7090, E7090 and its Metabolites
time frame: Day 1: 0-672 hours post-dose
measure: T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites
time frame: Day 1: 0-672 hours post-dose
measure: CL/F: Apparent Total Body Clearance for E7090
time frame: Day 1: 0-672 hours post-dose
measure: Vd/F: Apparent Volume of Distribution for E7090
time frame: Day 1: 0-672 hours post-dose
measure: MPR AUC(0-inf): Metabolite to Parent Ratio For AUC(0-inf) of Metabolite to E7090, Corrected for Molecular Weights
time frame: Day 1: 0-672 hours post-dose
measure: Metabolic profile of E7090: Concentration of Metabolite of E7090 in Plasma, Urine, and Feces
time frame: Up to Day 57
description: Blood, urine and feces samples will be collected and analyzed to estimate the concentration of metabolite of E7090 by Liquid Chromatography/ multiple-stage Mass Spectroscopy method.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: Baseline up to Day 57
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values
time frame: Baseline up to Day 29
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
time frame: Baseline up to Day 29
measure: Number of Participants With Clinically Significant Change From Baseline in 12 Lead Electrocardiogram (ECG) Findings
time frame: Baseline up to Day 29
measure: Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline up to Day 29
description: The C-SSRS is an interview-based rating scale to systematically assess any suicidality, any suicidal behavior, any suicidal ideation. Any suicidality: emergence of any suicidal ideation or suicidal behavior. Any suicidal behavior: when response is "yes" for any these questions- actual attempt to suicide, engaged in non-suicidal self-injurious behavior, interrupted attempt, aborted attempt, preparatory acts. Any suicidal ideation: when response is "yes" for any of these questions- wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent to suicide. Number of participants with any suicidality will be reported for this outcome measure.
measure: Number of Participants With Clinically Significant Change From Baseline in Ophthalmic Examinations
time frame: Baseline up to Day 29
description: Ophthalmic examinations includes visual acuity, funduscopy, optical coherence tomography, and slit-lamp examination.
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Examinations
time frame: Baseline up to Day 29
arm group label: E7090
arm group type: Experimental
description: Participants will receive 100 microcurie (μCi) of [14C]E7090 as a single 35 milligram (mg), capsule, orally on Day 1.
intervention type: Drug
intervention name: [14C]E7090
description: [14C]E7090, oral capsule.
arm group label: E7090
other name: E7090
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.