<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/NCT02223351</url>
  </required_header>
  <id_info>
    <org_study_id>M522101-EU22</org_study_id>
    <secondary_id>2014-002174-37</secondary_id>
    <nct_id>NCT02223351</nct_id>
  </id_info>
  <brief_title>Drug-Drug Interaction Study: ASP2151 and Ritonavir</brief_title>
  <official_title>A Single-centre, Open-label, Randomised, Crossover, Drug-drug Interaction Study to Investigate the Effect of a Single Oral Dose of Ritonavir on the Single Dose Pharmacokinetics of ASP2151 in Healthy Men</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maruho Europe Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maruho Europe Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to&#xD;
      contracting other infections because of their compromised immune system. As HIV patients will&#xD;
      be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one&#xD;
      of the drugs that is commonly prescribed to HIV patients (ritonavir).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax) of ASP2151</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Peak Concentration (Tmax) of ASP2151</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve (AUC) of ASP2151</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-Life (t1/2) of ASP2151</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Volume of Distribution (Vd/F) of ASP2151</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious and Non-Serious Adverse Events</measure>
    <time_frame>Up to 31 days</time_frame>
    <description>Refer to the result of adverse event.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Peak Plasma Concentration (Cmax) of ASP1955888-00</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
    <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time of Peak Concentration (Tmax) of ASP1955888-00</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
    <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
  </other_outcome>
  <other_outcome>
    <measure>Area Under the Curve (AUC) of ASP1955888-00</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
    <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
  </other_outcome>
  <other_outcome>
    <measure>Half-life (t1/2) of ASP1955888-00</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
    <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
  </other_outcome>
  <other_outcome>
    <measure>Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
    <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
  </other_outcome>
  <other_outcome>
    <measure>Apparent Volume of Distribution (Vd/F) of ASP1955888-00</measure>
    <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
    <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>400mg ASP2151</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1200mg ASP2151</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASP2151</intervention_name>
    <arm_group_label>1200mg ASP2151</arm_group_label>
    <arm_group_label>400mg ASP2151</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ritonavir</intervention_name>
    <arm_group_label>1200mg ASP2151</arm_group_label>
    <arm_group_label>400mg ASP2151</arm_group_label>
    <other_name>Norvir</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Sufficient intelligence to understand the nature of the trial and any hazards of&#xD;
             participating in it. Ability to communicate satisfactorily with the investigator and&#xD;
             to participate in, and comply with the requirements of, the entire trial.&#xD;
&#xD;
          -  Willingness to give written consent to participate after reading the information and&#xD;
             consent form, and after having the opportunity to discuss the trial with the&#xD;
             investigator or his delegate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant abnormal history, physical findings, ECG, or laboratory values at&#xD;
             the pre-trial screening assessment that could interfere with the objectives of the&#xD;
             trial or the safety of the volunteer.&#xD;
&#xD;
          -  Any of the following liver function tests higher than 1.5 times the ULN at the&#xD;
             screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT),&#xD;
             ALP, bilirubin, gamma glutamyl transpeptidase (gamma-GT).&#xD;
&#xD;
          -  Platelet counts outside normal limits.&#xD;
&#xD;
          -  Presence of acute or chronic illness or history of chronic illness sufficient to&#xD;
             invalidate the volunteer's participation in the trial or make it unnecessarily&#xD;
             hazardous.&#xD;
&#xD;
          -  Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal&#xD;
             function, diabetes mellitus, coronary heart disease, or history of any psychotic&#xD;
             mental illness.&#xD;
&#xD;
          -  History of bleeding diathesis.&#xD;
&#xD;
          -  Surgery (eg stomach bypass) or medical condition that might affect absorption of&#xD;
             medicines.&#xD;
&#xD;
          -  Presence or history of severe adverse reaction to any drug, history of multiple drug&#xD;
             allergies (multiple defined as &gt;3), or sensitivity to trial medication.&#xD;
&#xD;
          -  Use, during the 28 days before the first dose of trial medication, of any prescription&#xD;
             medicine, or any other medicine or herbal remedy (such as St John's wort) known to&#xD;
             interfere with the CYP3A4 metabolic pathway (unless judged as not clinical significant&#xD;
             by the investigator and sponsor).&#xD;
&#xD;
          -  Use, during the 7 days before the first dose of trial medication, of any&#xD;
             over-the-counter medicine, with the exception of paracetamol (acetaminophen).&#xD;
&#xD;
          -  Participation in another clinical trial of a new chemical entity or a prescription&#xD;
             medicine within the previous 3 months.&#xD;
&#xD;
          -  Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood&#xD;
             donor.&#xD;
&#xD;
          -  Presence or history of drug or alcohol abuse, or intake of more than 21 units of&#xD;
             alcohol weekly or more than 10 cigarettes daily.&#xD;
&#xD;
          -  Evidence of drug abuse on urine testing.&#xD;
&#xD;
          -  Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.&#xD;
&#xD;
          -  Blood pressure (BP) and heart rate (HR) in seated position at the screening&#xD;
             examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart&#xD;
             rate 40_100 beats/min.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hammersmith Medicines Research Ltd</name>
      <address>
        <city>London</city>
        <zip>NW10 7EW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>July 9, 2018</results_first_submitted>
  <results_first_submitted_qc>July 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2019</results_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HSV</keyword>
  <keyword>HIV</keyword>
  <keyword>Herpes</keyword>
  <keyword>volunteers</keyword>
  <keyword>drug-drug interaction</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at one investigative site in United Kingdom from 05-September 2014 to 04-December 2014</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>400mg ASP2151</title>
          <description>ASP2151 400mg alone followed by ASP2151 400mg + 600 mg ritonavir, or vice versa.</description>
        </group>
        <group group_id="P2">
          <title>1200mg ASP2151</title>
          <description>ASP2151 1200mg alone followed by ASP2151 1200mg + 600 mg ritonavir, or vice versa.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>First Intervention (8 Days)</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Wasout (2weeks)</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Second Intervention (8 Days)</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>400mg ASP2151</title>
          <description>ASP2151 400mg alone followed by ASP2151 400mg + 600 mg ritonavir, or vice versa.</description>
        </group>
        <group group_id="B2">
          <title>1200mg ASP2151</title>
          <description>ASP2151 1200mg alone followed by ASP2151 1200mg + 600 mg ritonavir, or vice versa.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="48"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.2" spread="6.4"/>
                    <measurement group_id="B2" value="27" spread="4.9"/>
                    <measurement group_id="B3" value="27.6" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Peak Plasma Concentration (Cmax) of ASP2151</title>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Plasma Concentration (Cmax) of ASP2151</title>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1845.7" spread="25.4"/>
                    <measurement group_id="O2" value="2518.7" spread="21.9"/>
                    <measurement group_id="O3" value="3804" spread="28.8"/>
                    <measurement group_id="O4" value="6211.6" spread="29.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time of Peak Concentration (Tmax) of ASP2151</title>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Peak Concentration (Tmax) of ASP2151</title>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="4" lower_limit="1.00" upper_limit="10.00"/>
                    <measurement group_id="O3" value="3.025" lower_limit="1.00" upper_limit="4.12"/>
                    <measurement group_id="O4" value="4" lower_limit="2.00" upper_limit="12.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Curve (AUC) of ASP2151</title>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) of ASP2151</title>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23162.4" spread="34.2"/>
                    <measurement group_id="O2" value="60225.3" spread="23"/>
                    <measurement group_id="O3" value="48532.3" spread="29.3"/>
                    <measurement group_id="O4" value="162131.6" spread="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Half-Life (t1/2) of ASP2151</title>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Half-Life (t1/2) of ASP2151</title>
          <units>h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.375" spread="14.9"/>
                    <measurement group_id="O2" value="12.575" spread="15.9"/>
                    <measurement group_id="O3" value="7.178" spread="17.5"/>
                    <measurement group_id="O4" value="12.498" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma</title>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma</title>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.314" spread="7.2654"/>
                    <measurement group_id="O2" value="6.815" spread="1.6607"/>
                    <measurement group_id="O3" value="25.735" spread="7.5753"/>
                    <measurement group_id="O4" value="7.63" spread="1.9843"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Volume of Distribution (Vd/F) of ASP2151</title>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (Vd/F) of ASP2151</title>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190.1" spread="56.912"/>
                    <measurement group_id="O2" value="123.17" spread="28.366"/>
                    <measurement group_id="O3" value="266.33" spread="79.948"/>
                    <measurement group_id="O4" value="139.33" spread="43.231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious and Non-Serious Adverse Events</title>
        <description>Refer to the result of adverse event.</description>
        <time_frame>Up to 31 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>400 mg ASP2151 alone</description>
          </group>
          <group group_id="O2">
            <title>400 mg ASP2151 With Ritonavir</title>
            <description>400 mg ASP2151 with 600 mg ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>1200 mg ASP2151 alone</description>
          </group>
          <group group_id="O4">
            <title>1200 mg ASP2151 Withritonavir</title>
            <description>1200 mg ASP2151 with 600 mg ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious and Non-Serious Adverse Events</title>
          <description>Refer to the result of adverse event.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Non-serious adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>serious adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Peak Plasma Concentration (Cmax) of ASP1955888-00</title>
        <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Peak Plasma Concentration (Cmax) of ASP1955888-00</title>
          <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189.9" spread="27.7"/>
                    <measurement group_id="O2" value="21.6" spread="70.7"/>
                    <measurement group_id="O3" value="421.5" spread="36.7"/>
                    <measurement group_id="O4" value="56.2" spread="79.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time of Peak Concentration (Tmax) of ASP1955888-00</title>
        <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Peak Concentration (Tmax) of ASP1955888-00</title>
          <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
          <units>h</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1.00" upper_limit="4.07"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.00" upper_limit="12.07"/>
                    <measurement group_id="O3" value="3" lower_limit="1.98" upper_limit="6.00"/>
                    <measurement group_id="O4" value="1.01" lower_limit="0.5" upper_limit="23.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Area Under the Curve (AUC) of ASP1955888-00</title>
        <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Curve (AUC) of ASP1955888-00</title>
          <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2636.2" spread="25.8"/>
                    <measurement group_id="O2" value="744.4" spread="12"/>
                    <measurement group_id="O3" value="6023.1" spread="30.2"/>
                    <measurement group_id="O4" value="1646.1" spread="37.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Half-life (t1/2) of ASP1955888-00</title>
        <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Half-life (t1/2) of ASP1955888-00</title>
          <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
          <units>h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.063" spread="18.1"/>
                    <measurement group_id="O2" value="40.213" spread="56.6"/>
                    <measurement group_id="O3" value="7.617" spread="18.6"/>
                    <measurement group_id="O4" value="42.197" spread="69.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00</title>
        <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00</title>
          <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
          <units>L/h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156.72" spread="43.197"/>
                    <measurement group_id="O2" value="540.93" spread="68.554"/>
                    <measurement group_id="O3" value="207.45" spread="59.311"/>
                    <measurement group_id="O4" value="775.35" spread="315.166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Apparent Volume of Distribution (Vd/F) of ASP1955888-00</title>
        <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
        <time_frame>Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>400 mg ASP2151 Alone</title>
            <description>ASP2151(400 mg) alone</description>
          </group>
          <group group_id="O2">
            <title>400mg ASP2151 With Ritonavir</title>
            <description>400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
          <group group_id="O3">
            <title>1200 mg ASP2151 Alone</title>
            <description>ASP2151(1200 mg) alone</description>
          </group>
          <group group_id="O4">
            <title>1200mg ASP2151 With Ritonavir</title>
            <description>1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir&#xD;
ASP2151&#xD;
ritonavir</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution (Vd/F) of ASP1955888-00</title>
          <description>ASP1955888-00 is a metabolite of the study drug (ASP2151)</description>
          <units>L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1840.8" spread="559.49"/>
                    <measurement group_id="O2" value="21474" spread="4135.72"/>
                    <measurement group_id="O3" value="2340.7" spread="877.14"/>
                    <measurement group_id="O4" value="27624.2" spread="14413.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 31 days after the final dose</time_frame>
      <group_list>
        <group group_id="E1">
          <title>400 mg ASP2151 Alone</title>
          <description>400 mg ASP2151 alone</description>
        </group>
        <group group_id="E2">
          <title>400 mg ASP2151 With Ritonavir</title>
          <description>400 mg ASP2151 with 600 mg ritonavir</description>
        </group>
        <group group_id="E3">
          <title>1200 mg ASP2151 Alone</title>
          <description>1200 mg ASP2151 alone</description>
        </group>
        <group group_id="E4">
          <title>1200 mg ASP2151 With Ritonavir</title>
          <description>1200 mg ASP2151 with 600 mg ritonavir</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="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA/17.0</default_vocab>
        <default_assessment>Non-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="8" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sensitivity of teeth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Catheter site related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Maruho Co.,Ltd. Kyoto R&amp;D Center</name_or_title>
      <organization>Clinical Development Dept.</organization>
      <phone>+81-75-325-3255</phone>
      <email>ctinfo@mii.maruho.co.jp</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/NCT02223351
org study id: M522101-EU22
secondary id: 2014-002174-37
nct id: NCT02223351
lead sponsor: 
has dmc: No
ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to
      contracting other infections because of their compromised immune system. As HIV patients will
      be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one
      of the drugs that is commonly prescribed to HIV patients (ritonavir).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax) of ASP2151
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
measure: Time of Peak Concentration (Tmax) of ASP2151
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
measure: Area Under the Curve (AUC) of ASP2151
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
measure: Half-Life (t1/2) of ASP2151
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
measure: Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
measure: Apparent Volume of Distribution (Vd/F) of ASP2151
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
measure: Number of Participants With Serious and Non-Serious Adverse Events
time frame: Up to 31 days
description: Refer to the result of adverse event.
measure: Peak Plasma Concentration (Cmax) of ASP1955888-00
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
description: ASP1955888-00 is a metabolite of the study drug (ASP2151)
measure: Time of Peak Concentration (Tmax) of ASP1955888-00
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
description: ASP1955888-00 is a metabolite of the study drug (ASP2151)
measure: Area Under the Curve (AUC) of ASP1955888-00
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
description: ASP1955888-00 is a metabolite of the study drug (ASP2151)
measure: Half-life (t1/2) of ASP1955888-00
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
description: ASP1955888-00 is a metabolite of the study drug (ASP2151)
measure: Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
description: ASP1955888-00 is a metabolite of the study drug (ASP2151)
measure: Apparent Volume of Distribution (Vd/F) of ASP1955888-00
time frame: Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
description: ASP1955888-00 is a metabolite of the study drug (ASP2151)
arm group label: 400mg ASP2151
arm group type: Other
description: 400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir
arm group label: 1200mg ASP2151
arm group type: Other
description: 1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir
intervention type: Drug
intervention name: ASP2151
arm group label: 1200mg ASP2151
arm group label: 400mg ASP2151
intervention type: Drug
intervention name: ritonavir
arm group label: 1200mg ASP2151
arm group label: 400mg ASP2151
other name: Norvir
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Ritonavir
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 