<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/NCT04448561</url>
  </required_header>
  <id_info>
    <org_study_id>8062-CL-2002</org_study_id>
    <secondary_id>UG3DA051392</secondary_id>
    <nct_id>NCT04448561</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants</brief_title>
  <official_title>A Phase 1 Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study was to assess the safety and tolerability of multiple doses&#xD;
      of ASP8062 or placebo alone and in combination with a single dose of morphine.&#xD;
&#xD;
      This study also assessed the potential for pharmacokinetic interaction between ASP8062 and&#xD;
      morphine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were screened for up to 28 days prior to first investigational product&#xD;
      administration. Eligible participants were admitted to the clinical unit on day -1 and were&#xD;
      residential for a single period of 17 days/16 nights.&#xD;
&#xD;
      Participants were discharged from the clinical unit on day 16 on the condition that all&#xD;
      required assessments had been performed and that there were no medical reasons for a longer&#xD;
      stay in the clinical unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">September 11, 2020</completion_date>
  <primary_completion_date type="Actual">September 11, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>From first dose of study drug up to end of study visit (up to day 25)</time_frame>
    <description>Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With At Least One Event of Suicidal Ideation And/or Suicidal Behavior as Assessed by The Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Up to day 25</time_frame>
    <description>The C-SSRS is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants with at least one affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and predose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and predose Day 10</time_frame>
    <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 1 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 1 hour postdose Day 10</time_frame>
    <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 2 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 2 hour postdose Day 10</time_frame>
    <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 4 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 4 hour postdose Day 10</time_frame>
    <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 8 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 8 hour postdose Day 10</time_frame>
    <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 12 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 12 hour postdose Day 10</time_frame>
    <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and predose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and predose Day 10</time_frame>
    <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 1 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 1 hour postdose Day 10</time_frame>
    <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 2 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 2 hour postdose Day 10</time_frame>
    <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 4 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 4 hour postdose Day 10</time_frame>
    <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose</measure>
    <time_frame>'ASP8062' and 'Placebo': Baseline and 8 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 8 hour postdose Day 10</time_frame>
    <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration From Time of Dosing to 24 Hours (AUC24)</measure>
    <time_frame>'ASP8062': Predose, 0.25, 0.5, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 h postdose Day 9; 'ASP8062 in combination with morphine': Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 h postdose Day 10</time_frame>
    <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>'ASP8062': Predose, 0.25, 0.5, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 h Day 9; 'ASP8062 in combination with morphine': Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 h postdose Day 10</time_frame>
    <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration From Time of Dosing Extrapolated to Time Infinity (AUCinf)</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>AUCinf was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>AUClast was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine in Plasma: Cmax</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>Cmax was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide(M3G) (Morphine Metabolite) in Plasma: AUCinf</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>AUCinf was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: AUClast</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>AUClast was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: Cmax</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>Cmax was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUCinf</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>AUCinf was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUClast</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>AUClast was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: Cmax</measure>
    <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
    <description>Cmax was recorded from the PK plasma samples collected.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Opioid Use Disorder</condition>
  <arm_group>
    <arm_group_label>ASP8062 in combination with morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo in combination with morphine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP8082</intervention_name>
    <description>oral</description>
    <arm_group_label>ASP8062 in combination with morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>morphine</intervention_name>
    <description>oral</description>
    <arm_group_label>ASP8062 in combination with morphine</arm_group_label>
    <arm_group_label>Placebo in combination with morphine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral</description>
    <arm_group_label>Placebo in combination with morphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is a recreational opioid user who has used opioids for nontherapeutic&#xD;
             (recreational) purposes on at least 10 occasions within their lifetime, with at least&#xD;
             1 opioid use in the last 90 days.&#xD;
&#xD;
          -  Participant has a body mass index (BMI) range of 18 to 36 kg/m^2, inclusive and weighs&#xD;
             at least 50 kg at screening.&#xD;
&#xD;
          -  Female participant is not pregnant and at least 1 of the following conditions apply:&#xD;
&#xD;
               -  Not a woman of childbearing potential (WOCBP)&#xD;
&#xD;
               -  WOCBP who agrees to follow the contraceptive guidance from the time of informed&#xD;
                  consent through at least 28 days after final investigational product (IP)&#xD;
                  administration.&#xD;
&#xD;
          -  Female participant must agree not to breastfeed starting at screening and throughout&#xD;
             the study period and for 28 days after final IP administration.&#xD;
&#xD;
          -  Female participant must not donate ova starting at first dose of IP and throughout the&#xD;
             study period and for 28 days after final IP administration.&#xD;
&#xD;
          -  Male participant with female partner(s) of childbearing potential (including&#xD;
             breastfeeding partner[s]) must agree to use contraception throughout the treatment&#xD;
             period and for 90 days after final IP administration.&#xD;
&#xD;
          -  Male participant must not donate sperm during the treatment period and for 90 days&#xD;
             after final IP administration.&#xD;
&#xD;
          -  Male participant with a pregnant partner(s) must agree to remain abstinent or use a&#xD;
             condom with spermicide for the duration of the pregnancy throughout the study period&#xD;
             and for 90 days after final IP administration.&#xD;
&#xD;
          -  Participant agrees to not participate in another interventional study while&#xD;
             participating in the present study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has received any investigational therapy within 28 days or 5 half-lives,&#xD;
             whichever is longer, prior to screening.&#xD;
&#xD;
          -  Participant has any condition which makes the participant unsuitable for study&#xD;
             participation.&#xD;
&#xD;
          -  Female participant who has been pregnant within 6 months prior to screening or&#xD;
             breastfeeding within 3 months prior to screening.&#xD;
&#xD;
          -  Participant has a known or suspected hypersensitivity to ASP8062 or morphine and/or&#xD;
             other opioids, or any components of the formulations used.&#xD;
&#xD;
          -  Participant has had previous exposure with ASP8062.&#xD;
&#xD;
          -  Participant has any of the liver function tests (alkaline phosphatase [ALP], alanine&#xD;
             aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase&#xD;
             and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1. In such a&#xD;
             case, the assessment may be repeated once.&#xD;
&#xD;
          -  Participant has any clinically significant history of allergic conditions (including&#xD;
             drug allergies, asthma or anaphylactic reactions, but excluding untreated,&#xD;
             asymptomatic, seasonal allergies) prior to first IP administration.&#xD;
&#xD;
          -  Participant has any history or evidence of any clinically significant cardiovascular,&#xD;
             gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,&#xD;
             urologic, pulmonary, neurologic, dermatologic, renal and/or other major disease or&#xD;
             malignancy with exception of history of cholecystectomy.&#xD;
&#xD;
          -  Participant has a history of moderate or severe use disorder for any substance other&#xD;
             than caffeine or tobacco (based on the Diagnostic and Statistical Manual of Mental&#xD;
             Disorders, edition 5 (DSM-5) criteria).&#xD;
&#xD;
          -  Participant has a history or presence of any clinically significant psychiatric&#xD;
             disorders such as, bipolar 1, schizophrenia, schizoaffective disorder or major&#xD;
             depressive disorders.&#xD;
&#xD;
          -  Participant has had recent suicidal ideation within the last 12 months or participant&#xD;
             who is at significant risk to commit suicide using the Baseline/Screening&#xD;
             Columbia-suicide severity rating scale (C-SSRS) at screening and the Since Last Visit&#xD;
             C-SSRS on day -1.&#xD;
&#xD;
          -  Participant has/had febrile illness or symptomatic, viral, bacterial (including upper&#xD;
             respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day&#xD;
             -1.&#xD;
&#xD;
          -  Participant has any clinically significant abnormality following an investigator's&#xD;
             review of the physical examination, ECG and protocol-defined clinical laboratory tests&#xD;
             at screening or on day -1.&#xD;
&#xD;
          -  Participant has a mean pulse &lt; 50 or &gt; 90 bpm; mean systolic blood pressure &gt; 150&#xD;
             mmHg; mean diastolic blood pressure &gt; 95 mmHg (measurements taken in duplicate after&#xD;
             participant has been resting in the supine position for at least 5 minutes) on day -1.&#xD;
             If the mean blood pressure exceeds the limits above, 1 additional duplicate may be&#xD;
             taken.&#xD;
&#xD;
          -  Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of &gt;&#xD;
             450 msec (for male participants) and &gt; 470 msec (for female participants) on day -1.&#xD;
             If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.&#xD;
&#xD;
          -  Participant has a positive test for amphetamines, barbiturates, benzodiazepines,&#xD;
             cocaine, phencyclidine, alcohol and/or opiates on day -1. Positive&#xD;
             tetrahydrocannabinol is not exclusionary and a cannabis intoxication evaluation will&#xD;
             be performed. Participant may be reconsidered.&#xD;
&#xD;
          -  Participant has used any prescribed or nonprescribed drugs (including vitamins and&#xD;
             natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to first IP&#xD;
             administration, except for occasional use of acetaminophen (up to 2 g/day), topical&#xD;
             dermatological products, including corticosteroid products, hormonal contraceptives&#xD;
             and hormone replacement therapy (HRT).&#xD;
&#xD;
          -  Participant must be willing to abstain from smoking (including use of&#xD;
             tobacco-containing products and nicotine or nicotine-containing products [e.g.,&#xD;
             electronic vapes]) from at least 1 hour predose through at least 8 hours postdose on&#xD;
             days 9 and 10.&#xD;
&#xD;
          -  Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in&#xD;
             the 3 months prior to day -1.&#xD;
&#xD;
          -  Participant has had significant blood loss, donated approximately 500 mL of whole&#xD;
             blood (excluding plasma donation) within 56 days prior to screening or donated plasma&#xD;
             within 7 days prior to day -1.&#xD;
&#xD;
          -  Participant has a positive serology test for hepatitis B surface antigen, hepatitis C&#xD;
             virus antibodies or antibodies to human immunodeficiency virus (HIV) type 1 and/or&#xD;
             type 2 at screening.&#xD;
&#xD;
          -  Participant has loss of ability to freely provide consent through imprisonment or&#xD;
             involuntary incarceration for treatment of either a psychiatric or physical (e.g.,&#xD;
             infectious disease) illness.&#xD;
&#xD;
          -  Participant is an employee of Astellas, the study-related contract research&#xD;
             organizations (CROs) or the clinical unit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Executive Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Altasciences Clinical Kansas, Inc.</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <results_first_submitted>September 1, 2021</results_first_submitted>
  <results_first_submitted_qc>September 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 29, 2021</results_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid Use Disorder</keyword>
  <keyword>pharmacokinetic</keyword>
  <keyword>ASP8062</keyword>
  <keyword>morphine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT04448561/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants who were recreational opioid users were enrolled in this study. Participants were enrolled in one site in the United States.</recruitment_details>
      <pre_assignment_details>Eligible participants were randomized to ASP8062 or placebo using 2:1 ratio according to the randomization schedule. Participants who met the inclusion criteria and met none of the exclusion criteria were enrolled. A total of 54 participants were screened, out of which 30 participants failed screening.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ASP8062 in Combination With Morphine</title>
          <description>Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
        </group>
        <group group_id="P2">
          <title>Placebo in Combination With Morphine</title>
          <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized: All participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>ASP8062 in Combination With Morphine</title>
          <description>Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
        </group>
        <group group_id="B2">
          <title>Placebo in Combination With Morphine</title>
          <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</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="16"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.4" spread="8.9"/>
                    <measurement group_id="B2" value="35.4" spread="10.4"/>
                    <measurement group_id="B3" value="32.7" spread="9.4"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood Oxygen Saturation (SpO2)</title>
          <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Baseline for SpO2 measurement was the last non-missing observation prior to first administration of ASP8062 or placebo.</description>
          <units>Percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98.1" spread="1.0"/>
                    <measurement group_id="B2" value="98.8" spread="0.9"/>
                    <measurement group_id="B3" value="98.3" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>End Tidal Carbon Dioxide (CO2)</title>
          <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. The baseline for end tidal CO2 measurement was day 9, prior to dosing with ASP8062 or placebo.</description>
          <population>Safety Analysis Set (SAF) with baseline value taken at Day 9. SAF included all participants randomly assigned to ASP8062 or placebo and who took at least 1 dose of ASP8062 or placebo. One participant from arm ASP8062 discontinued from study on day 2.</population>
          <units>millimeter of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="8"/>
                    <count group_id="B3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.1" spread="3.1"/>
                    <measurement group_id="B2" value="36.3" spread="2.2"/>
                    <measurement group_id="B3" value="36.8" spread="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.</description>
        <time_frame>From first dose of study drug up to end of study visit (up to day 25)</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants randomly assigned to investigational product (ASP8062 or placebo) and who took at least 1 dose of investigational product (ASP8062 or placebo).</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.</description>
          <population>The analysis population was the SAF, which consisted of all participants randomly assigned to investigational product (ASP8062 or placebo) and who took at least 1 dose of investigational product (ASP8062 or placebo).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug related TEAE leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE leading to withdrawal of treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-related TEAE leading to withdrawal of treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With At Least One Event of Suicidal Ideation And/or Suicidal Behavior as Assessed by The Columbia-Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The C-SSRS is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants with at least one affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported.</description>
        <time_frame>Up to day 25</time_frame>
        <population>The analysis population was the SAF.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With At Least One Event of Suicidal Ideation And/or Suicidal Behavior as Assessed by The Columbia-Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The C-SSRS is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants with at least one affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported.</description>
          <population>The analysis population was the SAF.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose</title>
        <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and predose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and predose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose</title>
          <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>SAF population with available data at each time point.</population>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="1.3"/>
                    <measurement group_id="O2" value="0.3" spread="1.2"/>
                    <measurement group_id="O3" value="-0.5" spread="0.8"/>
                    <measurement group_id="O4" value="-0.6" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose</title>
        <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 1 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 1 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose</title>
          <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>SAF population with available data at each time point.</population>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.4"/>
                    <measurement group_id="O2" value="-0.7" spread="1.4"/>
                    <measurement group_id="O3" value="-0.5" spread="1.4"/>
                    <measurement group_id="O4" value="-1.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose</title>
        <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 2 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 2 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose</title>
          <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>SAF population with available data at each time point.</population>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="1.2"/>
                    <measurement group_id="O2" value="-0.5" spread="1.6"/>
                    <measurement group_id="O3" value="-0.9" spread="1.1"/>
                    <measurement group_id="O4" value="-0.6" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose</title>
        <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 4 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 4 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose</title>
          <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>SAF population with available data at each time point.</population>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="1.5"/>
                    <measurement group_id="O2" value="-0.2" spread="1.1"/>
                    <measurement group_id="O3" value="-0.5" spread="1.1"/>
                    <measurement group_id="O4" value="-1.0" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose</title>
        <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 8 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 8 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose</title>
          <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>SAF population with available data at each time point.</population>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="1.6"/>
                    <measurement group_id="O2" value="-0.5" spread="2.3"/>
                    <measurement group_id="O3" value="-1.1" spread="1.8"/>
                    <measurement group_id="O4" value="-0.5" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose</title>
        <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 12 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 12 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose</title>
          <description>The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>SAF population with available data at each time point.</population>
          <units>percentage of oxygen saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="1.6"/>
                    <measurement group_id="O2" value="-0.5" spread="1.3"/>
                    <measurement group_id="O3" value="-1.5" spread="1.8"/>
                    <measurement group_id="O4" value="-1.3" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose</title>
        <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and predose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and predose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose</title>
          <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
          <population>SAF population with available data at each time point.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">predose CO2 assessment was not performed for this group on Day 9.</measurement>
                    <measurement group_id="O2" value="-1.0" spread="2.4"/>
                    <measurement group_id="O3" value="NA" spread="NA">predose CO2 assessment was not performed for this group on Day 9.</measurement>
                    <measurement group_id="O4" value="0.5" spread="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose</title>
        <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 1 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 1 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose</title>
          <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
          <population>SAF population with available data at each time point.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="2.4"/>
                    <measurement group_id="O2" value="0.7" spread="2.3"/>
                    <measurement group_id="O3" value="-0.4" spread="4.4"/>
                    <measurement group_id="O4" value="2.5" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose</title>
        <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 2 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 2 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose</title>
          <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
          <population>SAF population with available data at each time point.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="2.5"/>
                    <measurement group_id="O2" value="2.5" spread="3.2"/>
                    <measurement group_id="O3" value="-1.0" spread="1.9"/>
                    <measurement group_id="O4" value="4.1" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose</title>
        <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 4 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 4 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose</title>
          <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
          <population>SAF population with available data at each time point.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.7"/>
                    <measurement group_id="O2" value="1.0" spread="2.6"/>
                    <measurement group_id="O3" value="0.1" spread="2.5"/>
                    <measurement group_id="O4" value="3.3" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose</title>
        <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
        <time_frame>'ASP8062' and 'Placebo': Baseline and 8 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 8 hour postdose Day 10</time_frame>
        <population>SAF population with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O3">
            <title>Placebo</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O4">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose</title>
          <description>End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.</description>
          <population>SAF population with available data at each time point.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.3"/>
                    <measurement group_id="O2" value="2.7" spread="3.3"/>
                    <measurement group_id="O3" value="2.1" spread="1.5"/>
                    <measurement group_id="O4" value="5.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration From Time of Dosing to 24 Hours (AUC24)</title>
        <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.</description>
        <time_frame>'ASP8062': Predose, 0.25, 0.5, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 h postdose Day 9; 'ASP8062 in combination with morphine': Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 h postdose Day 10</time_frame>
        <population>The analysis population was Pharmacokinetic Analysis Set (PKAS) with available data at each time point. PKAS consisted of all participants who received at least 1 dose of ASP8062 for which concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter of ASP8062.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration From Time of Dosing to 24 Hours (AUC24)</title>
          <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.</description>
          <population>The analysis population was Pharmacokinetic Analysis Set (PKAS) with available data at each time point. PKAS consisted of all participants who received at least 1 dose of ASP8062 for which concentration data were available to facilitate derivation of at least 1 pharmacokinetic parameter of ASP8062.</population>
          <units>nanogram*hour per milliliter(ng*h/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1640" spread="619"/>
                    <measurement group_id="O2" value="1640" spread="589"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric Least square (LS) mean ratio</param_type>
            <param_value>100.64</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>98.37</ci_lower_limit>
            <ci_upper_limit>102.96</ci_upper_limit>
            <estimate_desc>Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Plasma Concentration (Cmax)</title>
        <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.</description>
        <time_frame>'ASP8062': Predose, 0.25, 0.5, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 h Day 9; 'ASP8062 in combination with morphine': Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 h postdose Day 10</time_frame>
        <population>The analysis population was PKAS with available data at each time point.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062</title>
            <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Plasma Concentration (Cmax)</title>
          <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.</description>
          <population>The analysis population was PKAS with available data at each time point.</population>
          <units>nanogram per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124" spread="41.1"/>
                    <measurement group_id="O2" value="116" spread="31.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LS mean ratio</param_type>
            <param_value>94.28</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>89.29</ci_lower_limit>
            <ci_upper_limit>99.54</ci_upper_limit>
            <estimate_desc>Assessment based on analysis of variance performed on natural log-transformed parameters with treatment as fixed effect and participant as random effect. Ratios and confidence limits: transformed back to raw scale and values expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration From Time of Dosing Extrapolated to Time Infinity (AUCinf)</title>
        <description>AUCinf was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration From Time of Dosing Extrapolated to Time Infinity (AUCinf)</title>
          <description>AUCinf was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128" spread="43.5"/>
                    <measurement group_id="O2" value="166" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)</title>
        <description>AUClast was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)</title>
          <description>AUClast was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was PKAS.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160" spread="39.8"/>
                    <measurement group_id="O2" value="158" spread="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LS mean ratio</param_type>
            <param_value>100.79</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>83.35</ci_lower_limit>
            <ci_upper_limit>121.88</ci_upper_limit>
            <estimate_desc>Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine in Plasma: Cmax</title>
        <description>Cmax was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine in Plasma: Cmax</title>
          <description>Cmax was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was PKAS.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="9.17"/>
                    <measurement group_id="O2" value="42.3" spread="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LS mean ratio</param_type>
            <param_value>100.58</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>81.35</ci_lower_limit>
            <ci_upper_limit>124.36</ci_upper_limit>
            <estimate_desc>Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide(M3G) (Morphine Metabolite) in Plasma: AUCinf</title>
        <description>AUCinf was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide(M3G) (Morphine Metabolite) in Plasma: AUCinf</title>
          <description>AUCinf was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5720" spread="980"/>
                    <measurement group_id="O2" value="6580" spread="702"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: AUClast</title>
        <description>AUClast was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: AUClast</title>
          <description>AUClast was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was PKAS.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5340" spread="887"/>
                    <measurement group_id="O2" value="5960" spread="703"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LS mean ratio</param_type>
            <param_value>89.08</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>79.58</ci_lower_limit>
            <ci_upper_limit>99.71</ci_upper_limit>
            <estimate_desc>Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: Cmax</title>
        <description>Cmax was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: Cmax</title>
          <description>Cmax was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was PKAS.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="933" spread="189"/>
                    <measurement group_id="O2" value="967" spread="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LS mean ratio</param_type>
            <param_value>96.11</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>83.03</ci_lower_limit>
            <ci_upper_limit>111.25</ci_upper_limit>
            <estimate_desc>Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUCinf</title>
        <description>AUCinf was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was the PKAS with available at each time point. The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUCinf</title>
          <description>AUCinf was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was the PKAS with available at each time point. The analysis population was PKAS with available data at each time point. Insufficient number of samples were available for calculation for AUCinf.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="821" spread="138"/>
                    <measurement group_id="O2" value="1100" spread="212"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUClast</title>
        <description>AUClast was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was the PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUClast</title>
          <description>AUClast was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was the PKAS.</population>
          <units>ng*h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="871" spread="161"/>
                    <measurement group_id="O2" value="1000" spread="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LS mean ratio</param_type>
            <param_value>86.54</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.01</ci_lower_limit>
            <ci_upper_limit>98.52</ci_upper_limit>
            <estimate_desc>Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits are transformed back to raw scale and values are expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: Cmax</title>
        <description>Cmax was recorded from the PK plasma samples collected.</description>
        <time_frame>Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10</time_frame>
        <population>The analysis population was the PKAS.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Morphine</title>
            <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Combination With Morphine</title>
            <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: Cmax</title>
          <description>Cmax was recorded from the PK plasma samples collected.</description>
          <population>The analysis population was the PKAS.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184" spread="37.6"/>
                    <measurement group_id="O2" value="192" spread="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Geometric LS mean ratio</param_type>
            <param_value>95.10</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>82.52</ci_lower_limit>
            <ci_upper_limit>109.60</ci_upper_limit>
            <estimate_desc>Assessment based on an analysis of variance performed on natural log-transformed parameters with treatment as a fixed effect. Ratios and confidence limits were transformed back to raw scale and values were expressed as percentages.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug up to end of study visit (up to day 25)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ASP8062</title>
          <description>Participants received ASP8062 tablet, orally once daily on days 1 through 9.</description>
        </group>
        <group group_id="E2">
          <title>ASP8062 in Combination With Morphine</title>
          <description>Participants received ASP8062 tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.</description>
        </group>
        <group group_id="E3">
          <title>Placebo</title>
          <description>Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 9. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
        </group>
        <group group_id="E4">
          <title>Placebo in Combination With Morphine</title>
          <description>Participants received ASP8062 matching placebo tablet, orally once on day 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Feeling of relaxation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Vessel puncture site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </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>Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosure</name_or_title>
      <organization>Astellas Pharma Global Development, Inc.</organization>
      <phone>800-888-7704</phone>
      <email>astellas.resultsdisclosure@astellas.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/NCT04448561
org study id: 8062-CL-2002
secondary id: UG3DA051392
nct id: NCT04448561
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary purpose of this study was to assess the safety and tolerability of multiple doses
      of ASP8062 or placebo alone and in combination with a single dose of morphine.

      This study also assessed the potential for pharmacokinetic interaction between ASP8062 and
      morphine.
Participants were screened for up to 28 days prior to first investigational product
      administration. Eligible participants were admitted to the clinical unit on day -1 and were
      residential for a single period of 17 days/16 nights.

      Participants were discharged from the clinical unit on day 16 on the condition that all
      required assessments had been performed and that there were no medical reasons for a longer
      stay in the clinical unit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Adverse Events (AEs)
time frame: From first dose of study drug up to end of study visit (up to day 25)
description: Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A Treatment emergent AE (TEAE) was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization.
measure: Number of Participants With At Least One Event of Suicidal Ideation And/or Suicidal Behavior as Assessed by The Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Up to day 25
description: The C-SSRS is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants with at least one affirmative response to the 5 items for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and/or to the 5 items for suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide) were reported.
measure: Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose
time frame: 'ASP8062' and 'Placebo': Baseline and predose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and predose Day 10
description: The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
measure: Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 1 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 1 hour postdose Day 10
description: The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
measure: Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 2 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 2 hour postdose Day 10
description: The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
measure: Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 4 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 4 hour postdose Day 10
description: The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
measure: Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 8 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 8 hour postdose Day 10
description: The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
measure: Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 12 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline and 12 hour postdose Day 10
description: The SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'. Baseline observation was last non-missing observation prior to first dose.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose
time frame: 'ASP8062' and 'Placebo': Baseline and predose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and predose Day 10
description: End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 1 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 1 hour postdose Day 10
description: End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 2 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 2 hour postdose Day 10
description: End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 4 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 4 hour postdose Day 10
description: End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose
time frame: 'ASP8062' and 'Placebo': Baseline and 8 hour postdose Day 9; 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine': Baseline (observation taken at Day 9), and 8 hour postdose Day 10
description: End tidal CO2 measurement was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 9 minus Baseline for arms 'ASP8062' and 'Placebo', and Day 10 minus Baseline (baseline observation was observation before first dose at Day 9) for arms 'ASP8062 in combination with morphine' and 'Placebo in combination with morphine'.
measure: Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration From Time of Dosing to 24 Hours (AUC24)
time frame: 'ASP8062': Predose, 0.25, 0.5, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 h postdose Day 9; 'ASP8062 in combination with morphine': Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 h postdose Day 10
description: AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.
measure: Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Plasma Concentration (Cmax)
time frame: 'ASP8062': Predose, 0.25, 0.5, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 h Day 9; 'ASP8062 in combination with morphine': Predose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144 h postdose Day 10
description: Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062' at Day 9, and for arm 'ASP8062 in combination with morphine' at Day 10.
measure: Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration From Time of Dosing Extrapolated to Time Infinity (AUCinf)
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: AUCinf was recorded from the PK plasma samples collected.
measure: Pharmacokinetics (PK) of Morphine in Plasma: Area Under the Concentration Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: AUClast was recorded from the PK plasma samples collected.
measure: Pharmacokinetics (PK) of Morphine in Plasma: Cmax
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: Cmax was recorded from the PK plasma samples collected.
measure: Pharmacokinetics (PK) of Morphine-3β-D-glucuronide(M3G) (Morphine Metabolite) in Plasma: AUCinf
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: AUCinf was recorded from the PK plasma samples collected.
measure: Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: AUClast
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: AUClast was recorded from the PK plasma samples collected.
measure: Pharmacokinetics (PK) of Morphine-3β-D-glucuronide (M3G) (Morphine Metabolite) in Plasma: Cmax
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: Cmax was recorded from the PK plasma samples collected.
measure: Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUCinf
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: AUCinf was recorded from the PK plasma samples collected.
measure: Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: AUClast
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: AUClast was recorded from the PK plasma samples collected.
measure: Pharmacokinetics (PK) of Morphine-6β-D-glucuronide (M6G) (Morphine Metabolite) in Plasma: Cmax
time frame: Predose, 0.25, 0.5, 1.5, 2, 3, 4, 8, 12, 16, 24, 36, 48 h postdose Day 10
description: Cmax was recorded from the PK plasma samples collected.
arm group label: ASP8062 in combination with morphine
arm group type: Experimental
description: Participants received ASP8062 tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 dose.
arm group label: Placebo in combination with morphine
arm group type: Placebo Comparator
description: Participants received ASP8062 matching placebo tablet, orally once daily on days 1 through 10. On day 10, participants also received morphine tablet as single oral dose immediately after the ASP8062 matching placebo dose.
intervention type: Drug
intervention name: ASP8082
description: oral
arm group label: ASP8062 in combination with morphine
intervention type: Drug
intervention name: morphine
description: oral
arm group label: ASP8062 in combination with morphine
arm group label: Placebo in combination with morphine
intervention type: Drug
intervention name: Placebo
description: oral
arm group label: Placebo in combination with morphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Executive Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Morphine
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 