<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/NCT02252354</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-385-1009</org_study_id>
    <secondary_id>2014-001564-35</secondary_id>
    <secondary_id>U1111-1159-5663</secondary_id>
    <secondary_id>14/WA/1087</secondary_id>
    <nct_id>NCT02252354</nct_id>
  </id_info>
  <brief_title>TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study</brief_title>
  <official_title>An Open-Label, Single-Centre,Two Part Phase I Mass Balance Study to Assess the Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability of Orally Administered [14C]-TAK-385 in Healthy Male 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and&#xD;
      removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral&#xD;
      tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will consist of 2 parts involving up to 12 healthy male participants. In Part 1, up&#xD;
      to 6 participants will receive a single 80 mg dose of [14C]-TAK-385 administered as an oral&#xD;
      solution. In Part 2, up to 6 participants will receive a single oral 80 mg dose of TAK-385&#xD;
      administered as two 40 mg tablets and an 80 μg intravenous (into a vein) dose of&#xD;
      [14C]-TAK-385 (containing not more than 37.0kBq [1000 nCi] 14C).&#xD;
&#xD;
      This single centre study will take place in the United Kingdom.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
    <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
    <description>Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
    <description>AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
    <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
    <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to Day 288) post-dose</time_frame>
    <description>Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168hours) post-dose</time_frame>
    <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose</time_frame>
    <description>AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
    <description>AUC(0-inf) is measure of area under the curve from time 0 to Infinity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 2: Absolute Bioavailability for the Oral Tablet Formulation</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity</measure>
    <time_frame>0 to 191 hours post-dose</time_frame>
    <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity</measure>
    <time_frame>0 to 144 hours post-dose</time_frame>
    <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose</measure>
    <time_frame>0 to 191 hours post-dose</time_frame>
    <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose</measure>
    <time_frame>0 to 144 hours post-dose</time_frame>
    <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose</measure>
    <time_frame>Hour 1 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose</measure>
    <time_frame>Hour 2 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose</measure>
    <time_frame>Hour 4 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose</measure>
    <time_frame>Hour 8 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose</measure>
    <time_frame>Hour 12 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose</measure>
    <time_frame>Hour 24 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose</measure>
    <time_frame>Hour 36 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose</measure>
    <time_frame>Hour 48 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose</measure>
    <time_frame>Hour 72 post-dose</time_frame>
    <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Part 1: Apparent Oral Clearance (CL/F) for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Apparent Oral Clearance (CL/F) for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 1: Volume of Distribution (Vz/F) for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Volume of Distribution (Vz/F) for TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose</time_frame>
    <description>Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part 2: Clearance (CL) for [14C]-TAK-385</measure>
    <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
    <description>CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Part 1: [14C]-TAK-385</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>[14C]-TAK-385 80 mg, solution, orally, once on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: TAK-385 + [14C]-TAK-385 IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 μg, infusion, intravenous once on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-TAK-385 Oral Solution</intervention_name>
    <description>TAK-385 oral radiolabelled solution</description>
    <arm_group_label>Part 1: [14C]-TAK-385</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-385 Tablets</intervention_name>
    <description>TAK-385 tablets 2 X 40 mg</description>
    <arm_group_label>Part 2: TAK-385 + [14C]-TAK-385 IV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[14C]-TAK-385 Solution for Intravenous Infusion</intervention_name>
    <description>TAK-385 intravenous (IV) radiolabelled solution</description>
    <arm_group_label>Part 2: TAK-385 + [14C]-TAK-385 IV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signs a written, informed consent form prior to the initiation of any study&#xD;
             procedures.&#xD;
&#xD;
          2. Is a healthy male, aged 18 to 55; inclusive on Day-1.&#xD;
&#xD;
          3. Is capable of understanding and complying with protocol requirements.&#xD;
&#xD;
          4. Weighs at least 50 kg and has a body mass index (BMI) between 18.0 and 35.0 kg/m^2,&#xD;
             inclusive at Screening or Day-1.&#xD;
&#xD;
          5. In the opinion of the investigator, is in good healthy condition on the basis of a&#xD;
             pre-study physical examination, medical history, vital signs, electrocardiogram, and&#xD;
             the results of blood biochemistry, hematology, and serology test and urinalysis at&#xD;
             Screening and Day -1.&#xD;
&#xD;
          6. A male participant who is nonsterilized and sexually active with a female partner of&#xD;
             childbearing potential agrees to use adequate contraception from signing of informed&#xD;
             consent throughout the duration of the study and for 90 days after last dose.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has received any investigational compound within 45 days prior to Day -1.&#xD;
&#xD;
          2. Has received TAK-385 in a previous clinical study.&#xD;
&#xD;
          3. Has a resting systolic blood pressure ≤90 mmHg or ≥140 mmHg and a resting diastolic&#xD;
             blood pressure ≤50 mmHg or ≥90 mmHg in supine position at Screening or Day-1.&#xD;
&#xD;
          4. QTc (Fridericia's correction) is &gt;450 msec at Screening or at Day -1 as read on the&#xD;
             printout of the ECG produced by the electrocardiogram (ECG) equipment and evaluated by&#xD;
             the investigator&#xD;
&#xD;
          5. Has active liver disease or jaundice, or with alanine aminotransferase (ALT),aspartate&#xD;
             aminotransferase (AST), or bilirubin (total bilirubin) &gt;1.5 times the upper limit of&#xD;
             normal (ULN) in the clinical laboratory tests at VISIT 1 and 2. The participant has&#xD;
             positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus&#xD;
             antibody (anti-HCV) or known history of human immunodeficiency virus (HIV) at&#xD;
             Screening.&#xD;
&#xD;
          6. Has a resting pulse and heart rate (as read on ECG) &lt;45 beats per minute (bpm) or &gt;100&#xD;
             bpm at Screening or Day -1.&#xD;
&#xD;
          7. Has had an acute, clinically significant illness within 30 days prior to Day -1.&#xD;
&#xD;
          8. Has a history or clinical manifestations of significant metabolic (including diabetes&#xD;
             mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary,&#xD;
             cardiovascular,gastrointestinal, neurological, rheumatologic, skin and subcutaneous&#xD;
             tissue disorders,infectious, hepatic, renal, urologic, immunologic, psychiatric or&#xD;
             mood disorders (including any past history of suicide attempt), or history of lactose&#xD;
             intolerance.&#xD;
&#xD;
          9. Has a family history of bleeding disorders.&#xD;
&#xD;
         10. Has current or recent (within 6 months) history of gastrointestinal disease that would&#xD;
             be expected to influence the absorption of drugs (ie, history of&#xD;
             malabsorption,esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent&#xD;
             heartburn, or any surgical intervention).&#xD;
&#xD;
         11. Has irregular defecation patterns (less than one defecation per two days or excessive&#xD;
             diarrhea) and/or has a history of changes in bowel habits with daily routine or&#xD;
             environment changes.&#xD;
&#xD;
         12. Radiation exposure, including that from the present study, excluding background&#xD;
             radiation but including diagnostic x-rays and other medical exposures, exceeding 5&#xD;
             millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No&#xD;
             occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999,&#xD;
             shall participate in the study&#xD;
&#xD;
         13. Has a history of abdominal surgery (except laparoscopic cholecystectomy or&#xD;
             uncomplicated appendectomy), thoracic or nonperipheral vascular surgery within 6&#xD;
             months prior to Day - 1.&#xD;
&#xD;
         14. Has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of&#xD;
             the skin that has not been in remission for at least 5 years prior to Day 1.&#xD;
&#xD;
         15. Has significant cardiovascular disease including, but not limited to, a history of&#xD;
             myocardial infarction, coronary angioplasty or bypass graft, unstable angina pectoris,&#xD;
             transient ischemic attacks, clinically significant abnormal ECGs, New York Heart&#xD;
             Association (NYHA) Functional Classification III or IV, or documented cerebrovascular&#xD;
             accident within 6 months prior to Day -1.&#xD;
&#xD;
         16. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol&#xD;
             abuse (defined as regular or daily consumption of more than 4 alcoholic drinks per&#xD;
             day) within 1 year prior to the Screening Visit.&#xD;
&#xD;
         17. Has used any tobacco (ie, nicotine) products (including but not limited to cigarettes,&#xD;
             pipe, cigar, chewing tobacco, nicotine patch, or nicotine gum) within 6 months prior&#xD;
             to Day -1 or is unwilling to abstain from these products for the duration of the study&#xD;
             or has a positive carbon monoxide test result at Screening or Day -1.&#xD;
&#xD;
         18. Has taken any medications, supplements or food products as described in the Excluded&#xD;
             Medications section. A subject has a positive carbon monoxide test result on Day-1.&#xD;
&#xD;
         19. Has poor peripheral venous access.&#xD;
&#xD;
         20. Is unwilling or unable to comply with the protocol or scheduled appointments&#xD;
&#xD;
         21. Is unable to understand verbal and/or written English.&#xD;
&#xD;
         22. Is a study site employee, or is an immediate family member (ie, spouse, parent, child,&#xD;
             and sibling) of a study site employee, involved in conduct of this study.&#xD;
&#xD;
         23. Has received or donated more than 400 mL of blood or blood products within the 45 days&#xD;
             preceding the beginning of the study or plans to donate blood during the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <results_first_submitted>October 27, 2015</results_first_submitted>
  <results_first_submitted_qc>October 27, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 1, 2015</results_first_posted>
  <last_update_submitted>September 22, 2016</last_update_submitted>
  <last_update_submitted_qc>September 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Relugolix</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 1 investigative site in United Kingdom from 29 September 2014 to 27 October 2014.</recruitment_details>
      <pre_assignment_details>Healthy cohort of male participants were enrolled in this 2 part study, in 1 of 2 treatment groups as follows : Part 1: [14C]-TAK-385 80 milligram (mg); Part 2:TAK-385 80 mg + [14C]-TAK-385 80 microgram (mcg)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: [14C]-TAK-385</title>
          <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Part 2: TAK-385 + [14C]-TAK-385</title>
          <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </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>Safety analysis set (SAS) included all participants who were enrolled and received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Part 1: [14C]-TAK-385</title>
          <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
          <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Greater than(&gt;)17 to less than equal to(&lt;=)64</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than one race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Caffeine Consumption</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <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>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Xanthine Consumption</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Classification</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Never smoked</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Current smoker</title>
              <category_list>
                <category>
                  <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>
              <title>Ex-smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol Classification</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>The participant has never drunk</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The participant is a current drinker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>The participant is an ex-drinker</title>
              <category_list>
                <category>
                  <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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385</title>
        <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
        <population>Pharmacokinetic (PK) set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385</title>
          <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.</description>
          <population>Pharmacokinetic (PK) set included all participants in the safety set with at least one measurable plasma concentration.</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>Whole Blood Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.4354" lower_limit="0.2" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.4354" lower_limit="0.2" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385</title>
        <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385</title>
          <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.4748" lower_limit="0.2" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385</title>
        <description>Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385</title>
          <description>Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng eq/mL</units>
          <param>Geometric 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>Whole Blood Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.6" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.1" spread="34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385</title>
        <description>Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385</title>
          <description>Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.7" spread="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385</title>
        <description>AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385</title>
          <description>AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng eq*hr/mL</units>
          <param>Geometric 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>Whole Blood Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1521.5" spread="421.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1771.4" spread="476.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385</title>
        <description>AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) .</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385</title>
          <description>AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) .</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>nanogram hour per milliliter (ng*hr/mL)</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="382.2" spread="128.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385</title>
        <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385</title>
          <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng eq*hr/mL</units>
          <param>Geometric 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>Whole Blood Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="756.5" spread="229.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="982.7" spread="288.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385</title>
        <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385</title>
          <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng*hr/mL</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="357.5" spread="119.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385</title>
        <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385</title>
          <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>hours</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>Whole Blood Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="285.3" spread="32.9" lower_limit="255.9" upper_limit="333.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Plasma Radioactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.1" spread="22.0" lower_limit="192.4" upper_limit="246.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385</title>
        <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385</title>
          <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>hours</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.7" spread="6.6" lower_limit="53.6" upper_limit="69.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces</title>
        <description>Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).</description>
        <time_frame>Day 1 pre-dose and various time-points (up to Day 288) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces</title>
          <description>Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percent recovery of radioactivity</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>Urine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feces</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.7" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385</title>
        <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385</title>
          <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.0455" lower_limit="0.1" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385</title>
        <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385</title>
          <description>Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="2.0897" lower_limit="0.5" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385</title>
        <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385</title>
          <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng eq/mL</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385</title>
        <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385</title>
          <description>Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng/mL</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385</title>
        <description>AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
        <time_frame>Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385</title>
          <description>AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng eq*hr/mL</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385</title>
        <description>AUC(0-inf) is measure of area under the curve from time 0 to Infinity.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 288 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385</title>
          <description>AUC(0-inf) is measure of area under the curve from time 0 to Infinity.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng*hr/mL</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="225.2" spread="110.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385</title>
        <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385</title>
          <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng eq*hr/mL</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385</title>
        <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385</title>
          <description>AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>ng*hr/mL</units>
          <param>Geometric 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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="214.5" spread="106.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385</title>
        <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385</title>
          <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>hours</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.5" spread="16.2" lower_limit="96.0" upper_limit="134.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385</title>
        <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385</title>
          <description>Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>hours</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.6" spread="6.0" lower_limit="42.5" upper_limit="60.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 2: Absolute Bioavailability for the Oral Tablet Formulation</title>
        <description>Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Absolute Bioavailability for the Oral Tablet Formulation</title>
          <description>Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage bioavailability</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Apparent Oral Clearance (CL/F) for TAK-385</title>
        <description>CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Apparent Oral Clearance (CL/F) for TAK-385</title>
          <description>CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>L/hr</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="218.2" spread="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Apparent Oral Clearance (CL/F) for TAK-385</title>
        <description>CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Apparent Oral Clearance (CL/F) for TAK-385</title>
          <description>CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>L/hr</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="382.9" spread="154.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 1: Volume of Distribution (Vz/F) for TAK-385</title>
        <description>Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Volume of Distribution (Vz/F) for TAK-385</title>
          <description>Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>Liter (L)</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18878.7" spread="5114.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Volume of Distribution (Vz/F) for TAK-385</title>
        <description>Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Volume of Distribution (Vz/F) for TAK-385</title>
          <description>Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>L</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28245.1" spread="13011.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces</title>
        <description>Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces</title>
          <description>Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percent recovery of radioactivity</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>Urine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feces</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" spread="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity</title>
        <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).</description>
        <time_frame>0 to 191 hours post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity</title>
          <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of recovered radioactivity</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>Total 14[C]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data were not reported because none of the values were above lower limit of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.6" spread="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity</title>
        <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).</description>
        <time_frame>0 to 144 hours post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity</title>
          <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of recovered radioactivity</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>Total 14[C]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" spread="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.6" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data were not reported because none of the values were above lower limit of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data were not reported because none of the values were above lower limit of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data were not reported because none of the values were above lower limit of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.4" spread="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose</title>
        <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.</description>
        <time_frame>0 to 191 hours post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose</title>
          <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of 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>Total 14[C]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.6" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data were not reported because none of the values were above lower limit of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.6" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose</title>
        <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.</description>
        <time_frame>0 to 144 hours post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose</title>
          <description>Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of 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>Total 14[C]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data were not reported because none of the values were above lower limit of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data were not reported because none of the values were above lower limit of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data were not reported because none of the values were above lower limit of detection.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 1 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 2 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 4 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.8" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 8 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 12 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 24 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 36 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 48 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose</title>
        <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
        <time_frame>Hour 72 post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1: [14C]-TAK-385</title>
            <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose</title>
          <description>Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>percentage of dose</units>
          <param>Number</param>
          <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>Metabolite A and B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolite-C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TAK-385</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Part 2: Clearance (CL) for [14C]-TAK-385</title>
        <description>CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).</description>
        <time_frame>Day 1 pre-dose and various time-points (up to 168 hours) post-dose</time_frame>
        <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
            <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Part 2: Clearance (CL) for [14C]-TAK-385</title>
          <description>CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).</description>
          <population>PK set included all participants in the safety set with at least one measurable plasma concentration.</population>
          <units>L/hr</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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.4" spread="4.5"/>
                  </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 and no more than 30 days (+/- 2) after the last dose of study drug.</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>Part 1: [14C]-TAK-385</title>
          <description>[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Part 2: TAK-385 + [14C]-TAK-385 IV</title>
          <description>TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</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="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Micturition disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <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>No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.</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>clinicaltrialregistry@tpna.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/NCT02252354
org study id: TAK-385-1009
secondary id: 2014-001564-35
secondary id: U1111-1159-5663
secondary id: 14/WA/1087
nct id: NCT02252354
lead sponsor: 
has dmc: No
The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and
      removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral
      tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).
The study will consist of 2 parts involving up to 12 healthy male participants. In Part 1, up
      to 6 participants will receive a single 80 mg dose of [14C]-TAK-385 administered as an oral
      solution. In Part 2, up to 6 participants will receive a single oral 80 mg dose of TAK-385
      administered as two 40 mg tablets and an 80 μg intravenous (into a vein) dose of
      [14C]-TAK-385 (containing not more than 37.0kBq [1000 nCi] 14C).

      This single centre study will take place in the United Kingdom.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Part 1: Time to Reach the Maximum Plasma and Whole Blood Radioactivity Concentration (Cmax) for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
description: Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to no more than (NMT) 4.7 millibecquerel (MBq) (127 microcurie [mCi]). Cmax was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by accelerator mass spectrometry (AMS) method.
measure: Part 1: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).
measure: Part 1: Cmax: Maximum Observed Plasma and Whole Blood Radioactivity Concentration for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
description: Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). Cmax was measured in nanogram equivalent per milliliter (ng eq/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.
measure: Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).
measure: Part 1: AUC(0-inf): Area Under the Plasma and Whole Blood Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
description: AUC(0-inf) is measure of area under the curve from time 0 to infinity. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). AUC(0-inf) was measured in nanogram equivalent*hour per milliliter (ng eq*hr/mL) and was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.
measure: Part 1: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: AUC(0-inf) is area under the concentration-time curve from time 0 to infinity. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385) .
measure: Part 1: AUC(0-168): Area Under the Plasma and Whole Blood Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
description: AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-168]). Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.
measure: Part 1: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: AUC(0-168) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau]), where tau is the length of the dosing interval -168 hours in this study). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).
measure: Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma and Whole Blood Radioactivity for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
description: Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 4.7 MBq (127 mCi). It was calculated as disintegration per minute per mL (DPM/mL). Total [14C]-TAK-385 determination of plasma and whole blood samples was determined by AMS method.
measure: Part 1: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product ([14C]-TAK-385).
measure: Part 1: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces
time frame: Day 1 pre-dose and various time-points (up to Day 288) post-dose
description: Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant. Total [14-C] determination of urine and feces samples were determined by Liquid Scintillation Counting (LSC).
measure: Part 2: Tmax : Time to Reach the Maximum Plasma Radioactivity Concentration (Cmax) for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax. Radioactivity corresponds to NMT 37.0 kilobecquerel (kBq) (1000 nanocurie [nCi]). Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.
measure: Part 2: Tmax : Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
measure: Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168hours) post-dose
description: Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.
measure: Part 2: Cmax: Maximum Observed Plasma Radioactivity Concentration for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
measure: Part 2: AUC(0-inf): Area Under the Plasma Radioactivity Concentration-time Curve From Time 0 to Infinity for [14C]-TAK-385
time frame: Day 1 pre-dose and various sampling time-points (up to 168 hours) post-dose
description: AUC(0-inf) is measure of area under the curve from time 0 to Infinity. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).AUC(0-inf) was corrected according to Hamilton Pool result.Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.
measure: Part 2: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 288 hours) post-dose
description: AUC(0-inf) is measure of area under the curve from time 0 to Infinity.
measure: Part 2: AUC(0-168): Area Under the Plasma Radioactivity Concentration-Time Curve From Time 0 to 168 Hours Postdose for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: AUC(0-168) is measure of area under the curve over the dosing interval (tau), where tau is the length of the dosing interval :168 hours in this study (AUC(0-tau]). AUC(0-168) was corrected according to Hamilton Pool result.Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.
measure: Part 2: AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: AUC(0-168) is measure of area under the curve over the dosing interval (tau),where tau is the length of the dosing interval: 168 hours in this study (AUC(0-tau]). AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385.
measure: Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma Radioactivity for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).Total radioactivity and [14C]-TAK-385 determination of plasma samples was determined by AMS.
measure: Part 2: Terminal Phase Elimination Half-Life (t1/2z) in Plasma for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Terminal phase elimination half-life (t1/2z) is the time required for half of the drug to be eliminated from the blood.
measure: Part 2: Absolute Bioavailability for the Oral Tablet Formulation
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Absolute bioavailability, defined as the fraction or percentage of the unchanged, orally administered dose that is systemically available, relative to the total dose administered intravenously. AUC was corrected using the Hamilton Pool Data to get an AUC for TAK-385
measure: Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percent Radioactivity
time frame: 0 to 191 hours post-dose
description: Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).
measure: Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percent Radioactivity
time frame: 0 to 144 hours post-dose
description: Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of recovered radioactivity, are reported. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total radioactivity (total [14]C).Radioactivity corresponds to NMT 4.7 MBq (127 mCi).
measure: Part 1: Excretion of TAK-385 and Its Metabolites in Human Feces as Percentage of Dose
time frame: 0 to 191 hours post-dose
description: Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from feces, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.
measure: Part 1: Excretion of TAK-385 and Its Metabolites in Human Urine as Percentage of Dose
time frame: 0 to 144 hours post-dose
description: Amount of total [14]C, TAK-385, metabolite A, B, and C, and others excreted from urine, calculated as percentage of dose. Others were calculated by subtraction of the sum of the values for TAK-385, Metabolite-A, Metabolite-B, and Metabolite-C from the value of the total [14]C.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 1 Post-dose
time frame: Hour 1 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 2 Post-dose
time frame: Hour 2 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 4 Post-dose
time frame: Hour 4 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 8 Post-dose
time frame: Hour 8 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 12 Post-dose
time frame: Hour 12 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 24 Post-dose
time frame: Hour 24 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 36 Post-dose
time frame: Hour 36 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 48 Post-dose
time frame: Hour 48 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: [14]C Distribution Profile From TAK-385 and Metabolites A, B, and C in Plasma Pools at Hour 72 Post-dose
time frame: Hour 72 post-dose
description: Percentage of [14]C as measured from TAK-385, metabolite A and B, and metabolite C in the plasma pools were calculated as the percentage of dose administered.
measure: Part 1: Apparent Oral Clearance (CL/F) for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr). CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.
measure: Part 2: Apparent Oral Clearance (CL/F) for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in liters/hour (L/hr).CL which was calculated by correcting the [14C]TAK-385 AUC, following the intravenous dose with the hamilton pool result to get a true CL (L/h).
measure: Part 1: Volume of Distribution (Vz/F) for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz). Plasma concentrations of TAK-385 were measured by high-performance liquid chromatography with tandem mass spectrometry method (LC-MS/MS). Correction of the LC-MS/MS derived concentrations were based upon the specific activity of the administered radiolabelled drug product.
measure: Part 2: Volume of Distribution (Vz/F) for TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: Vz/F is the distribution of a drug between plasma and the rest of the body following oral administration, calculated as CL/F divided by the terminal elimination rate constant (λz).
measure: Part 2: Overall Cumulative Percent Recovery of Total Dosed Radioactivity in Urine and Feces
time frame: Day 1 pre-dose and various time-points (up to 72 hours) post-dose for urine; Day 1 pre-dose and various time-points (up to 48 hours) post-dose
description: Overall cumulative percent of radioactive dose recovered in urine and feces is the total radioactivity excreted in urine and feces divided by the amount of total radioactivity dosed for each participant.
measure: Part 2: Clearance (CL) for [14C]-TAK-385
time frame: Day 1 pre-dose and various time-points (up to 168 hours) post-dose
description: CL is clearance of the drug from the plasma, calculated as the drug dose divided by AUC expressed in L/hr. CL is a quantitative measure of the rate at which a drug substance is removed from the body. Radioactivity corresponds to NMT 37.0 kBq (1000 nCi).
arm group label: Part 1: [14C]-TAK-385
arm group type: Experimental
description: [14C]-TAK-385 80 mg, solution, orally, once on Day 1.
arm group label: Part 2: TAK-385 + [14C]-TAK-385 IV
arm group type: Experimental
description: TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 μg, infusion, intravenous once on Day 1.
intervention type: Drug
intervention name: [14C]-TAK-385 Oral Solution
description: TAK-385 oral radiolabelled solution
arm group label: Part 1: [14C]-TAK-385
intervention type: Drug
intervention name: TAK-385 Tablets
description: TAK-385 tablets 2 X 40 mg
arm group label: Part 2: TAK-385 + [14C]-TAK-385 IV
intervention type: Drug
intervention name: [14C]-TAK-385 Solution for Intravenous Infusion
description: TAK-385 intravenous (IV) radiolabelled solution
arm group label: Part 2: TAK-385 + [14C]-TAK-385 IV
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pharmaceutical Solutions
mesh term: Relugolix
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 