<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/NCT04447287</url>
  </required_header>
  <id_info>
    <org_study_id>8062-CL-2003</org_study_id>
    <secondary_id>UG3DA051392</secondary_id>
    <nct_id>NCT04447287</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder</brief_title>
  <official_title>Phase 1b Randomized, Placebo-controlled Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Subjects With Opioid Use Disorder</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>Yes</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 buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose&#xD;
      of ASP8062.&#xD;
&#xD;
      This study also assessed the potential for pharmacokinetic interaction between ASP8062 and&#xD;
      buprenorphine/naloxone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were screened for up to 28 days prior to first investigational product (IP)&#xD;
      administration. Eligible participants were admitted to the clinical unit on day -1 and were&#xD;
      residential for a single period of 27 days/26 nights.&#xD;
&#xD;
      Participants were discharged from the clinical unit after completion of down-titration on the&#xD;
      condition that all required assessments were performed and that there were no medical reasons&#xD;
      for a longer stay in the clinical unit; which was the end-of-study visit (ESV). Prior to&#xD;
      discharge, participants were provided with local buprenorphine and methadone providers for&#xD;
      their reference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">November 25, 2020</completion_date>
  <primary_completion_date type="Actual">November 25, 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 27)</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. 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 Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Up to day 27</time_frame>
    <description>The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an 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>'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12</time_frame>
    <description>The blood oxygen saturation (SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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>'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12</time_frame>
    <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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>'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12</time_frame>
    <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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>'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12</time_frame>
    <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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>'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12</time_frame>
    <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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>'buprenorphine/naloxone': Baseline and 12 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 12 hour postdose Day 12</time_frame>
    <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and predose Day 12</time_frame>
    <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose</measure>
    <time_frame>'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12</time_frame>
    <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose</measure>
    <time_frame>'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12</time_frame>
    <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose</measure>
    <time_frame>'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12</time_frame>
    <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose</measure>
    <time_frame>'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12</time_frame>
    <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf)</measure>
    <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)</time_frame>
    <description>AUCinf was recorded from the PK plasma samples collected. Samples for AUCinf were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)</measure>
    <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)</time_frame>
    <description>AUClast was recorded from the PK plasma samples collected. Samples for AUClast were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Concentration (Cmax)</measure>
    <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)</time_frame>
    <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Buprenorphine in Plasma: Area Under the Concentration-time Curve From the Time of Dosing to 24 Hours (AUC24)</measure>
    <time_frame>Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)</time_frame>
    <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Buprenorphine in Plasma: Cmax</measure>
    <time_frame>Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)</time_frame>
    <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: AUC24</measure>
    <time_frame>Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)</time_frame>
    <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: Cmax</measure>
    <time_frame>Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)</time_frame>
    <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Naloxone in Plasma: AUC24</measure>
    <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 168, 216 and 264 hour(s)</time_frame>
    <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of Naloxone in Plasma: Cmax</measure>
    <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 168, 216 and 264 hour(s)</time_frame>
    <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Opioid Use Disorder</condition>
  <arm_group>
    <arm_group_label>ASP8062 in combination with buprenorphine/naloxone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo ASP8062 in combination with buprenorphine/naloxone</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP8062</intervention_name>
    <description>Oral</description>
    <arm_group_label>ASP8062 in combination with buprenorphine/naloxone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo ASP8062</intervention_name>
    <description>Oral</description>
    <arm_group_label>Placebo ASP8062 in combination with buprenorphine/naloxone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>buprenorphine/naloxone</intervention_name>
    <description>Sublingual</description>
    <arm_group_label>ASP8062 in combination with buprenorphine/naloxone</arm_group_label>
    <arm_group_label>Placebo ASP8062 in combination with buprenorphine/naloxone</arm_group_label>
    <other_name>Suboxone®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a body mass index range of 18 to 36 kg/m^2, inclusive and weighs at least&#xD;
             50 kg at screening.&#xD;
&#xD;
          -  Subject has a diagnosis of moderate or severe opioid use disorder (OUD) according to&#xD;
             the Diagnostic and Statistical Manual of Mental Disorders, edition 5 (DSM-5) at&#xD;
             screening.&#xD;
&#xD;
          -  Subject tests positive for opioids at screening and/or on day -1 or subject shows&#xD;
             signs of opioid withdrawal on day -1.&#xD;
&#xD;
          -  Subject is willing to take buprenorphine/naloxone and is not taking buprenorphine or&#xD;
             buprenorphine/naloxone at screening.&#xD;
&#xD;
          -  Female subject 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 30 days after final investigational product (IP)&#xD;
                  administration.&#xD;
&#xD;
          -  Female subject must agree not to breastfeed starting at screening and throughout the&#xD;
             study period and for 30 days after final IP administration.&#xD;
&#xD;
          -  Female subject must not donate ova starting at first dose of IP and throughout the&#xD;
             study period and for 30 days after final IP administration.&#xD;
&#xD;
          -  Male subject with female partner(s) of childbearing potential (including breastfeeding&#xD;
             partner) must agree to use contraception throughout the study period and for 90 days&#xD;
             after final IP administration.&#xD;
&#xD;
          -  Male subject must not donate sperm during the treatment period and for 90 days after&#xD;
             final IP administration.&#xD;
&#xD;
          -  Male subject with pregnant partner(s) must agree to remain abstinent or use a condom&#xD;
             and spermicide for the duration of the pregnancy throughout the study period and for&#xD;
             90 days after final IP administration.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study while participating&#xD;
             in the present study.&#xD;
&#xD;
          -  Subject must be willing to abstain from smoking (including use of tobacco containing&#xD;
             products and nicotine or nicotine-containing products [e.g., electronic vapes] from at&#xD;
             least 1 hour predose through at least 8 hours postdose on days 11 and 12.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has received any investigational therapy within 28 days or 5 half-lives,&#xD;
             whichever is longer, prior to screening.&#xD;
&#xD;
          -  Subject has any condition which makes the subject unsuitable for study participation.&#xD;
&#xD;
          -  Female subject who has been pregnant within 6 months prior to screening or&#xD;
             breastfeeding within 3 months prior to screening.&#xD;
&#xD;
          -  Subject has a known or suspected hypersensitivity to ASP8062, buprenorphine, naloxone&#xD;
             or any components of the formulations used.&#xD;
&#xD;
          -  Subject has had previous exposure with ASP8062.&#xD;
&#xD;
          -  Subject 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]) &gt; 2 × upper limit of normal (ULN) on day -1. In such a&#xD;
             case, the assessment may be repeated once.&#xD;
&#xD;
          -  Subject has any clinically significant history of allergic conditions (including drug&#xD;
             allergies, asthma or anaphylactic reactions, but excluding untreated, asymptomatic,&#xD;
             seasonal allergies) prior to first IP administration.&#xD;
&#xD;
          -  Subject 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;
          -  Subject has current or recent diagnosis (within the last 12 months) of moderate or&#xD;
             severe alcohol, sedative, hypnotic, anxiolytic, cocaine or any other substance use&#xD;
             disorder (except for opioids, caffeine, tobacco or nicotine) according to the DSM-5 at&#xD;
             screening.&#xD;
&#xD;
          -  Subject has a history or presence of any clinically significant psychiatric disorders&#xD;
             such as, bipolar 1, schizophrenia, schizoaffective disorder or major depressive&#xD;
             disorders.&#xD;
&#xD;
          -  Subject tests positive for alcohol, benzodiazepine or methadone on day -1. Subject&#xD;
             tests positive for buprenorphine on day -1.&#xD;
&#xD;
          -  Subject has had recent suicidal ideation within the last 12 months or subject who is&#xD;
             at significant risk to commit suicide using the Columbia-Suicide Severity Rating Scale&#xD;
             (C-SSRS) at screening or since the last visit on day -1.&#xD;
&#xD;
          -  Subject 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;
          -  Subject has any clinically significant abnormality following physical examination,&#xD;
             electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or&#xD;
             on day -1.&#xD;
&#xD;
          -  Subject has a mean pulse &lt; 45 or &gt; 110 beats per minute (unless out of range [&gt; 110&#xD;
             beats per minute] pulse is deemed to be secondary to opioid withdrawal); mean systolic&#xD;
             blood pressure &gt; 150 mmHg; mean diastolic blood pressure &gt; 95 mmHg (unless out of&#xD;
             range blood pressure is deemed to be secondary to opioid withdrawal)(measurements&#xD;
             taken in duplicate after subject has been resting in the supine position for at least&#xD;
             5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure&#xD;
             exceeds the limits above, 1 additional duplicate may be taken.&#xD;
&#xD;
          -  Subject has a mean corrected QT interval using Fridericia's formula (QTcF) of &gt; 450&#xD;
             msec (for male subjects) and &gt; 470 msec (for female subjects) on day -1. If the mean&#xD;
             QTcF exceeds the limits above, 1 additional duplicate ECG may be taken.&#xD;
&#xD;
          -  Subject has used any prescribed drugs, vitamins and natural or herbal remedies&#xD;
             (including, St. John's Wort) in the 2 weeks prior to first IP administration, except&#xD;
             for rescue medications, milk of magnesia, acetaminophen, topical dermatological&#xD;
             products, including corticosteroid products, hormonal contraceptives and hormone&#xD;
             replacement therapy (HRT).&#xD;
&#xD;
          -  Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3&#xD;
             months prior to day -1.&#xD;
&#xD;
          -  Subject has had significant blood loss or donated approximately 500 mL of whole blood&#xD;
             (excluding plasma donation) within 56 days prior to screening or donated plasma within&#xD;
             7 days prior to day -1.&#xD;
&#xD;
          -  Subject has a positive serology test for antibodies to human immunodeficiency virus&#xD;
             type 1 and/or type 2, acute hepatitis B virus infection or acute hepatitis C virus&#xD;
             infection, excluding asymptomatic hepatitis C virus infection at screening.&#xD;
&#xD;
          -  Subject 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;
          -  Subject is an employee of Astellas, the study-related contract research organizations&#xD;
             or the clinical unit.&#xD;
&#xD;
          -  Subject has used any inducer of CYP2C8, 2C9 or 3A4-related metabolism (e.g.,&#xD;
             barbiturates, rifampin, aprepitant, ritonavir, apalutamide, carbamazepine,&#xD;
             enzalutamide, mitotane, phenytoin, rifampin, St. John's wort, bosentan, efavirenz,&#xD;
             etravirine, phenobarbital, primidone, armodafinil, modafinil, and rufinamide) in the 3&#xD;
             months prior to day -1.&#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>December 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <results_first_submitted>November 1, 2021</results_first_submitted>
  <results_first_submitted_qc>December 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 12, 2022</results_first_posted>
  <last_update_submitted>December 14, 2021</last_update_submitted>
  <last_update_submitted_qc>December 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Suboxone®</keyword>
  <keyword>Opioid Use Disorder</keyword>
  <keyword>buprenorphine/naloxone</keyword>
  <keyword>ASP8062</keyword>
  <keyword>pharmacokinetic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Buprenorphine, Naloxone Drug Combination</mesh_term>
    <mesh_term>ASP8062</mesh_term>
    <mesh_term>Naloxone</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 29, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT04447287/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants who had opioid use disorder (OUD) were enrolled in this study. Participants were enrolled in one site in the United States.</recruitment_details>
      <pre_assignment_details>Participants were randomized using a 2:1 ratio. Eligible participants who met inclusion criteria and none of the exclusion criteria were enrolled. A total of 74 participants entered the screening process and out of which 56 discontinued prior to randomization. Prior to randomization, participants entered a run-in period. A total of 23 participants entered the run-in period and 19 completed, 1 participant completed the run-in period but discontinued before randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Buprenorphine/Naloxone</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
        </group>
        <group group_id="P2">
          <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
        </group>
        <group group_id="P3">
          <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period 1: Run-in Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 2: Investigational Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Completed the run-in period but discontinued before randomization due to limited samples collected.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Period 3: Down-Titration Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The analysis population consisted of all participants who received at least 1 dose of Investigational Product (IP) during Run-in Period; Investigational Period and Down-titration Period.</population>
      <group_list>
        <group group_id="B1">
          <title>Buprenorphine/Naloxone</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
        </group>
        <group group_id="B2">
          <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
        </group>
        <group group_id="B3">
          <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
        </group>
        <group group_id="B4">
          <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="5"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="23"/>
          </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="5"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.4" spread="5.2"/>
                    <measurement group_id="B2" value="40.2" spread="9.2"/>
                    <measurement group_id="B3" value="43.2" spread="10.3"/>
                    <measurement group_id="B4" value="41.2" spread="8.5"/>
                  </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="5"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="16"/>
                  </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="5"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" 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 group_id="B4" 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="5"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="23"/>
                  </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 group_id="B4" 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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </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 group_id="B4" 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 group_id="B4" 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 Investigational Product (IP).</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of IP during Run-in Period; Investigational Period and Down-titration Period.</population>
          <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="5"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98.2" spread="0.8"/>
                    <measurement group_id="B2" value="97.8" spread="1.9"/>
                    <measurement group_id="B3" value="97.8" spread="1.2"/>
                    <measurement group_id="B4" value="97.9" spread="1.5"/>
                  </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 is study Day 11, prior to dosing with ASP8062 or Placebo ASP8062.</description>
          <population>The analysis population consisted of all participants who received at least 1 dose of IP during Run-in Period; Investigational Period and Down-titration Period.</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="1"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="6"/>
                    <count group_id="B4" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40" spread="0"/>
                    <measurement group_id="B2" value="40.4" spread="4.1"/>
                    <measurement group_id="B3" value="38.2" spread="5.1"/>
                    <measurement group_id="B4" value="39.7" spread="4.3"/>
                  </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>An AE is defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. 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 27)</time_frame>
        <population>The analysis population was the Safety Analysis Set (SAF), which consisted of all participants who received at least 1 dose of ASP8062.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O4">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O5">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>An AE is defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. 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 Safety Analysis Set (SAF), which consisted of all participants who received at least 1 dose of ASP8062.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug-Related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="1"/>
                  </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 group_id="O5" 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 group_id="O5" 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 group_id="O5" 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 group_id="O5" 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 group_id="O5" 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 group_id="O5" 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 group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)</title>
        <description>The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an 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 27</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of Investigational Product (IP).</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O4">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O5">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)</title>
          <description>The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an 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, which consisted of all participants who received at least 1 dose of Investigational Product (IP).</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="23"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" 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 blood oxygen saturation (SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at Predose</title>
          <description>The blood oxygen saturation (SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="18"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="2.1"/>
                    <measurement group_id="O2" value="-0.4" spread="2.3"/>
                    <measurement group_id="O3" value="-0.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose</title>
        <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 1 Hour Postdose</title>
          <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="18"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="2.5"/>
                    <measurement group_id="O2" value="-0.6" spread="2.6"/>
                    <measurement group_id="O3" value="-0.7" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose</title>
        <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 2 Hour Postdose</title>
          <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="18"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="2.2"/>
                    <measurement group_id="O2" value="-0.8" spread="2.0"/>
                    <measurement group_id="O3" value="0.3" spread="1.8"/>
                  </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 blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 4 Hour Postdose</title>
          <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="18"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="1.9"/>
                    <measurement group_id="O2" value="-0.4" spread="1.7"/>
                    <measurement group_id="O3" value="-0.2" spread="1.2"/>
                  </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 blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 8 Hour Postdose</title>
          <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="18"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="2.3"/>
                    <measurement group_id="O2" value="-0.1" spread="2.4"/>
                    <measurement group_id="O3" value="0.7" 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 blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 12 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 12 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Oxygen Saturation (SpO2) at 12 Hour Postdose</title>
          <description>The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. Baseline observation was last non-missing observation prior to first dose.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="18"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.8"/>
                    <measurement group_id="O2" value="-0.3" spread="2.5"/>
                    <measurement group_id="O3" value="-0.5" spread="0.8"/>
                  </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 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
        <time_frame>'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and predose Day 12</time_frame>
        <population>The analysis population was the Safety Analysis Set (SAF), which consisted of all participants who received at least 1 dose of ASP8062. It was pre-specified to assess only the Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O2">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at Predose</title>
          <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
          <population>The analysis population was the Safety Analysis Set (SAF), which consisted of all participants who received at least 1 dose of ASP8062. It was pre-specified to assess only the Investigational Period Arms/Groups for this Outcome Measure.</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="12"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="4.0"/>
                    <measurement group_id="O2" value="0.5" spread="6.1"/>
                  </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 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose</title>
          <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="19"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="5.8"/>
                    <measurement group_id="O2" value="-0.5" spread="4.0"/>
                    <measurement group_id="O3" value="3.7" spread="7.2"/>
                  </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 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose</title>
          <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="19"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="5.1"/>
                    <measurement group_id="O2" value="0.3" spread="3.2"/>
                    <measurement group_id="O3" value="4.2" spread="5.0"/>
                  </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 4 Hour Postdose</title>
        <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose</title>
          <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="18"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="4.9"/>
                    <measurement group_id="O2" value="-1.0" spread="2.3"/>
                    <measurement group_id="O3" value="5.3" spread="7.9"/>
                  </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 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
        <time_frame>'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12</time_frame>
        <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone (Run-in Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose</title>
          <description>End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.</description>
          <population>The analysis population was the SAF, which consisted of all participants who received at least 1 dose of IP and had both baseline and post dose measures taken. It was pre-specified to assess only the Run-in Period and Investigational Period Arms/Groups for this Outcome Measure.</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="18"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="4.1"/>
                    <measurement group_id="O2" value="1.4" spread="1.9"/>
                    <measurement group_id="O3" value="6.0" spread="5.7"/>
                  </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-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf)</title>
        <description>AUCinf was recorded from the PK plasma samples collected. Samples for AUCinf were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
        <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)</time_frame>
        <population>The analysis population was the Pharmacokinetic Analysis Set (PKAS), which consisted of all participants who received at least 1 dose of ASP8062 for which concentration data was available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf)</title>
          <description>AUCinf was recorded from the PK plasma samples collected. Samples for AUCinf were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
          <population>The analysis population was the Pharmacokinetic Analysis Set (PKAS), which consisted of all participants who received at least 1 dose of ASP8062 for which concentration data was available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>h*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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4450" spread="1750"/>
                  </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-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)</title>
        <description>AUClast was recorded from the PK plasma samples collected. Samples for AUClast were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
        <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)</time_frame>
        <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of ASP8062 for which concentration data was available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP8062 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. Samples for AUClast were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
          <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of ASP8062 for which concentration data was available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>h*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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4270" spread="1620"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Concentration (Cmax)</title>
        <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
        <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)</time_frame>
        <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of ASP8062 for which concentration data was available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Concentration (Cmax)</title>
          <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.</description>
          <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of ASP8062 for which concentration data was available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152" spread="36.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Buprenorphine in Plasma: Area Under the Concentration-time Curve From the 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 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
        <time_frame>Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)</time_frame>
        <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of buprenorphine (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Buprenorphine in Plasma: Area Under the Concentration-time Curve From the 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 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
          <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of buprenorphine (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>h*pg/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="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63800" spread="20300"/>
                    <measurement group_id="O2" value="53500" spread="18300"/>
                    <measurement group_id="O3" value="67700" spread="18700"/>
                  </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>89.72</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>81.21</ci_lower_limit>
            <ci_upper_limit>99.11</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Buprenorphine in Plasma: Cmax</title>
        <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
        <time_frame>Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)</time_frame>
        <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of buprenorphine (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Buprenorphine in Plasma: Cmax</title>
          <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
          <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of buprenorphine (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>pg/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="18"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7790" spread="3280"/>
                    <measurement group_id="O2" value="6790" spread="3230"/>
                    <measurement group_id="O3" value="8440" spread="2200"/>
                  </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>92.15</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>80.22</ci_lower_limit>
            <ci_upper_limit>105.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: AUC24</title>
        <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
        <time_frame>Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)</time_frame>
        <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of buprenorphine (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: AUC24</title>
          <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
          <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of buprenorphine (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>h*pg/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="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97600" spread="49200"/>
                    <measurement group_id="O2" value="96200" spread="45700"/>
                    <measurement group_id="O3" value="104000" spread="43600"/>
                  </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>109.09</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>101.10</ci_lower_limit>
            <ci_upper_limit>117.71</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: Cmax</title>
        <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
        <time_frame>Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)</time_frame>
        <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of buprenorphine (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: Cmax</title>
          <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
          <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of buprenorphine (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>pg/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="18"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5260" spread="2350"/>
                    <measurement group_id="O2" value="6060" spread="2870"/>
                    <measurement group_id="O3" value="5730" spread="1930"/>
                  </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>117.77</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>106.41</ci_lower_limit>
            <ci_upper_limit>130.34</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Naloxone in Plasma: AUC24</title>
        <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
        <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 168, 216 and 264 hour(s)</time_frame>
        <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of naloxone (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Naloxone in Plasma: AUC24</title>
          <description>AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
          <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of naloxone (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>h*pg/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="16"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1270" spread="656"/>
                    <measurement group_id="O2" value="1060" spread="624"/>
                    <measurement group_id="O3" value="1090" spread="379"/>
                  </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>79.39</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>68.10</ci_lower_limit>
            <ci_upper_limit>92.55</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetics (PK) of Naloxone in Plasma: Cmax</title>
        <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
        <time_frame>Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 168, 216 and 264 hour(s)</time_frame>
        <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of naloxone (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
        <group_list>
          <group group_id="O1">
            <title>Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O2">
            <title>ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
          <group group_id="O3">
            <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone</title>
            <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetics (PK) of Naloxone in Plasma: Cmax</title>
          <description>Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.</description>
          <population>The analysis population was the PKAS, which consisted of all participants who received at least 1 dose of naloxone (in any applicable period) and for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.</population>
          <units>pg/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="18"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="464" spread="355"/>
                    <measurement group_id="O2" value="382" spread="284"/>
                    <measurement group_id="O3" value="363" spread="160"/>
                  </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>74.45</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>59.28</ci_lower_limit>
            <ci_upper_limit>93.50</ci_upper_limit>
          </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 27)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Buprenorphine/Naloxone</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. Participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
        </group>
        <group group_id="E2">
          <title>ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
        </group>
        <group group_id="E3">
          <title>ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</description>
        </group>
        <group group_id="E4">
          <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Investigational Period)</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 12 through 18. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12.</description>
        </group>
        <group group_id="E5">
          <title>Placebo ASP8062 in Combination With Buprenorphine/Naloxone (Down-titration Period)</title>
          <description>Participants received multiple sublingual doses of buprenorphine/naloxone on days 19 through 26. After randomization on day 12, participants received a single oral dose of Placebo concomitantly with buprenorphine/naloxone and underwent repeat intensive safety assessment on day 12. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.</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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v23.</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="16" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Drug withdrawal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Feeling of relaxation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="13" subjects_affected="8" subjects_at_risk="23"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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/NCT04447287
org study id: 8062-CL-2003
secondary id: UG3DA051392
nct id: NCT04447287
lead sponsor: 
collaborator: 
has dmc: Yes
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 buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose
      of ASP8062.

      This study also assessed the potential for pharmacokinetic interaction between ASP8062 and
      buprenorphine/naloxone.
Participants were screened for up to 28 days prior to first investigational product (IP)
      administration. Eligible participants were admitted to the clinical unit on day -1 and were
      residential for a single period of 27 days/26 nights.

      Participants were discharged from the clinical unit after completion of down-titration on the
      condition that all required assessments were performed and that there were no medical reasons
      for a longer stay in the clinical unit; which was the end-of-study visit (ESV). Prior to
      discharge, participants were provided with local buprenorphine and methadone providers for
      their reference.
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 27)
description: An AE is defined as any untoward medical occurrence in a participant administered an Investigational Product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding; abnormal laboratory test result or other safety assessment, symptom, or disease temporally associated with the use of IP whether or not considered related to the IP. A treatment-emergent adverse event (TEAE) was defined as an AE with onset at any time from first dosing until last scheduled procedure. 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 Suicidal Ideation and/or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: Up to day 27
description: The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinician administered assessment tool that evaluates suicidal ideation and behavior. Number of participants that have an 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: 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12
description: The blood oxygen saturation (SpO2 was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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: 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12
description: The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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: 'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12
description: The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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: 'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12
description: The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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: 'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12
description: The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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: 'buprenorphine/naloxone': Baseline and 12 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 12 hour postdose Day 12
description: The blood oxygen saturation (SpO2) was measured using a pulse oximeter placed on the participant's fingertip. Change from baseline in SpO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'. 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 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and predose Day 12
description: End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at 1 Hour Postdose
time frame: 'buprenorphine/naloxone': Baseline and 1 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 1 hour postdose Day 12
description: End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at 2 Hour Postdose
time frame: 'buprenorphine/naloxone': Baseline and 2 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 2 hour postdose Day 12
description: End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at 4 Hour Postdose
time frame: 'buprenorphine/naloxone': Baseline and 4 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 4 hour postdose Day 12
description: End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.
measure: Change From Baseline in End Tidal Carbon Dioxide (CO2) at 8 Hour Postdose
time frame: 'buprenorphine/naloxone': Baseline and 8 hour postdose Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone': Baseline and 8 hour postdose Day 12
description: End tidal CO2 measurements was obtained per participant utilizing a portable bedside capnography device. Change from baseline in CO2 was calculated as Day 11 minus Baseline for arm 'buprenorphine/naloxone', and Day 12 minus Baseline for arms 'ASP8062 in combination with buprenorphine/naloxone' and 'Placebo ASP8062 in combination with buprenorphine/naloxone'.
measure: Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf)
time frame: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)
description: AUCinf was recorded from the PK plasma samples collected. Samples for AUCinf were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.
measure: Pharmacokinetics (PK) of ASP8062 in Plasma: Area Under the Concentration-time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast)
time frame: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)
description: AUClast was recorded from the PK plasma samples collected. Samples for AUClast were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.
measure: Pharmacokinetics (PK) of ASP8062 in Plasma: Maximum Concentration (Cmax)
time frame: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, 120, 144, 168, 216 and 264 hour(s)
description: Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'ASP8062 in combination with buprenorphine/naloxone' at Day 12.
measure: Pharmacokinetics (PK) of Buprenorphine in Plasma: Area Under the Concentration-time Curve From the Time of Dosing to 24 Hours (AUC24)
time frame: Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)
description: AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.
measure: Pharmacokinetics (PK) of Buprenorphine in Plasma: Cmax
time frame: Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)
description: Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.
measure: Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: AUC24
time frame: Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)
description: AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.
measure: Pharmacokinetics (PK) of Norbuprenorphine (Buprenorphine's Metabolite) in Plasma: Cmax
time frame: Predose on day 11 and at the following postdose time points on day 11: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 16 hour(s)
description: Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.
measure: Pharmacokinetics (PK) of Naloxone in Plasma: AUC24
time frame: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 168, 216 and 264 hour(s)
description: AUC24 was recorded from the PK plasma samples collected. Samples for AUC24 were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.
measure: Pharmacokinetics (PK) of Naloxone in Plasma: Cmax
time frame: Predose on day 12 and at the following postdose time points on day 12: 0.25, 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 168, 216 and 264 hour(s)
description: Cmax was recorded from the PK plasma samples collected. Samples for Cmax were collected for arm 'buprenorphine/naloxone' at Day 11; 'ASP8062 in combination with buprenorphine/naloxone' and 'ASP8062 in combination with Placebo' at Day 12.
arm group label: ASP8062 in combination with buprenorphine/naloxone
arm group type: Experimental
description: Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of ASP8062 concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
arm group label: Placebo ASP8062 in combination with buprenorphine/naloxone
arm group type: Placebo Comparator
description: Participants received multiple sublingual doses of buprenorphine/naloxone on days 1 through 26. In the Investigational Period participants were on a stable daily dose of buprenorphine/naloxone on days 5 through 18. After randomization on day 12, participants received a single oral dose of placebo concomitantly with buprenorphine/naloxone. The stable dose of buprenorphine/naloxone was down titrated from days 19 through 26.
intervention type: Drug
intervention name: ASP8062
description: Oral
arm group label: ASP8062 in combination with buprenorphine/naloxone
intervention type: Drug
intervention name: Placebo ASP8062
description: Oral
arm group label: Placebo ASP8062 in combination with buprenorphine/naloxone
intervention type: Drug
intervention name: buprenorphine/naloxone
description: Sublingual
arm group label: ASP8062 in combination with buprenorphine/naloxone
arm group label: Placebo ASP8062 in combination with buprenorphine/naloxone
other name: Suboxone®
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: Substance-Related Disorders
mesh term: Buprenorphine
mesh term: Buprenorphine, Naloxone Drug Combination
mesh term: ASP8062
mesh term: Naloxone
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: 