<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/NCT04497883</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-620-1020</org_study_id>
    <nct_id>NCT04497883</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Participants Compared With Matched, Healthy, Non-Hispanic, Caucasian Participants and to Assess Dose-Proportionality of 3 Doses of Maribavir in Japanese Participants</brief_title>
  <official_title>A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Maribavir Administered in Healthy Japanese Subjects Compared With Matched, Healthy, Non-Hispanic, Caucasian Subjects and to Assess Dose-Proportionality of 3 Doses of Maribavir in the Japanese Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the pharmacokinetics (PK), safety, and tolerability&#xD;
      of maribavir administered as a single oral dose in healthy, adult participants of Japanese&#xD;
      descent and matched, healthy, adult, non-Hispanic, Caucasian participants. In addition, this&#xD;
      study will assess the dose-proportionality of PK of maribavir in healthy, adult participants&#xD;
      of Japanese descent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in two cohorts, Cohort A and Cohort B. Cohort A consists of 12&#xD;
      participants of Japanese Descent. Cohort B consists of 12 non-Hispanic, Caucasian&#xD;
      participants.&#xD;
&#xD;
      For Japanese participants there will be three treatment periods. In Treatment Period 1, they&#xD;
      will receive maribavir as a single 400 mg oral dose. In Treatment Periods 2 and 3, all&#xD;
      Japanese participants will receive maribavir as a single oral dose of either 200 mg or 800&#xD;
      mg, depending upon randomization assignment. For the non-Hispanic, Caucasian group there will&#xD;
      be only one treatment period and they will receive maribavir as a single 400 mg oral dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Actual">November 12, 2020</completion_date>
  <primary_completion_date type="Actual">November 12, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Maribavir</measure>
    <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
    <description>Cmax of maribavir in plasma were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir</measure>
    <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
    <description>AUClast of maribavir in plasma were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir</measure>
    <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
    <description>AUC(0-infinity) of maribavir in plasma were reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants</measure>
    <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
    <description>Dose proportionality was assessed using the power model including log-transformed Cmax dependent variable and the log-transformed dose as a fixed effect. Natural log (ln) and 90% confidence interval for the slope are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants</measure>
    <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
    <description>Dose proportionality was assessed using the power model including log-transformed AUClast dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants</measure>
    <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
    <description>Dose proportionality was assessed using the power model including log-transformed AUC0-inifinity dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs</measure>
    <time_frame>From start of study drug administration to follow-up (up to Day 23)</time_frame>
    <description>An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this investigational product (IP) or medicinal product. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported in both non-Hispanic, Caucasian and Japanese descent participants.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Cohort A: Non-Hispanic, Caucasian</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-Hispanic, Caucasian group participants will receive 400 milligram (mg) maribavir tablets orally once on Day 1 during treatment period 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B: Japanese Descent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1 followed by 200 mg or 800 mg maribavir tablets orally once on Day 1 during treatment period 2 followed by 800 mg or 200 mg maribavir tablets orally once on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours will be maintained between treatment period 1, 2, and 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maribavir (400 mg)</intervention_name>
    <description>Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.</description>
    <arm_group_label>Cohort A: Non-Hispanic, Caucasian</arm_group_label>
    <arm_group_label>Cohort B: Japanese Descent</arm_group_label>
    <other_name>SHP620</other_name>
    <other_name>TAK-620</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maribavir (200 mg)</intervention_name>
    <description>Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.</description>
    <arm_group_label>Cohort B: Japanese Descent</arm_group_label>
    <other_name>SHP620</other_name>
    <other_name>TAK-620</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maribavir (800 mg)</intervention_name>
    <description>Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.</description>
    <arm_group_label>Cohort B: Japanese Descent</arm_group_label>
    <other_name>SHP620</other_name>
    <other_name>TAK-620</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An understanding, ability, and willingness to fully comply with study procedures and&#xD;
             restrictions.&#xD;
&#xD;
          -  Ability to voluntarily provide written informed consent/assent as applicable to&#xD;
             participate in the study.&#xD;
&#xD;
          -  Healthy 18 to 55 years old participants of Japanese descent and non-Hispanic Caucasian&#xD;
             origin.&#xD;
&#xD;
          -  Healthy participants of Japanese descent must have been born in Japan and must not&#xD;
             have lived outside of Japan for greater than (&gt;) 10 years; both parents and all 4&#xD;
             grandparents must be of Japanese origin. Healthy, non-Hispanic, Caucasian participants&#xD;
             must have both parents and all 4 grandparents of non-Hispanic, Caucasian origin.&#xD;
&#xD;
          -  Male, or non-pregnant, non-breastfeeding female who agrees to comply with any&#xD;
             applicable contraceptive requirements of the protocol or females of non-childbearing&#xD;
             potential.&#xD;
&#xD;
          -  Hemoglobin for males greater than or equal to (&gt;=) 135.0 gram per liter (g/L) and&#xD;
             females &gt;= 120.0 g/L at screening and on Day -1.&#xD;
&#xD;
          -  Body mass index (BMI) between 18.5 and 28.0 kilogram per square meter (kg/m^2)&#xD;
             inclusive with a body weight &gt; 45 kilograms (kg) (99 pounds [lbs]).&#xD;
&#xD;
          -  Ability to swallow a dose of investigational product (IP).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any hematological, hepatic, respiratory, cardiovascular, renal,&#xD;
             neurological, or psychiatric disease, gall bladder removal, or current recurrent&#xD;
             disease.&#xD;
&#xD;
          -  Current or relevant history of physical or psychiatric illness, any medical disorder&#xD;
             that may require treatment or make the participant unlikely to fully complete the&#xD;
             study, or any condition that presents undue risk from the IP or procedures.&#xD;
&#xD;
          -  Known or suspected intolerance or hypersensitivity to maribavir, closely-related&#xD;
             compounds, or any of the stated ingredients.&#xD;
&#xD;
          -  Significant illness, as judged by the investigator, within 2 weeks of the first dose&#xD;
             of IP.&#xD;
&#xD;
          -  Donation of blood or blood products (e.g. plasma or platelets) within 60 days prior to&#xD;
             receiving the first dose of IP.&#xD;
&#xD;
          -  Have taken another IP within 30 days or five half-lives of that IP, whichever is&#xD;
             greater, prior to the first dose of maribavir.&#xD;
&#xD;
          -  Have been enrolled in a clinical study (including vaccine studies) within 30 days&#xD;
             prior to the first dose of IP that, in the investigator's opinion, may impact this&#xD;
             study.&#xD;
&#xD;
          -  Have had any substantial changes in eating habits within 30 days prior to the first&#xD;
             dose of IP, as assessed by the investigator.&#xD;
&#xD;
          -  Confirmed systolic blood pressure &gt; 139 millimeter of mercury (mmHg) or less than (&lt;)&#xD;
             89 mmHg, and diastolic blood pressure &gt; 89 mmHg or &lt; 49 mmHg.&#xD;
&#xD;
          -  Twelve-lead ECG demonstrating QTc &gt; 450 milliseconds (msec).&#xD;
&#xD;
          -  Known history of alcohol or other substance abuse, including synthetic cannabinoids&#xD;
             within the last year.&#xD;
&#xD;
          -  Male participants who consume more than 21 units of alcohol per week or 3 units per&#xD;
             day. Female participants who consume more than 14 units of alcohol per week or 2 units&#xD;
             per day.&#xD;
&#xD;
          -  A positive urine test for drugs of abuse, alcohol, or cotinine at screening or on Day&#xD;
             -1.&#xD;
&#xD;
          -  A positive human immunodeficiency virus (HIV), hepatitis B surface antibody (HBsAg),&#xD;
             or hepatitis C virus (HCV) antibody screen.&#xD;
&#xD;
          -  Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing&#xD;
             products in any form (e.g. gum, patch).&#xD;
&#xD;
          -  Routine consumption of more than 2 units of caffeine per day or participants who&#xD;
             experience caffeine withdrawal headaches.&#xD;
&#xD;
          -  Current use of any prescription medication within 30 days of the first dose of IP.&#xD;
             Current use of any over the counter medication within 14 days of the first dose of IP.&#xD;
&#xD;
          -  Ingestion of known cytochrome P450 (CYP) 3A modulators within 7 days of Day 1, period&#xD;
             1&#xD;
&#xD;
          -  History of active or chronic oral/nasal cavity infections, gastroesophageal reflux,&#xD;
             asthma treatment with albuterol, zinc supplementation.&#xD;
&#xD;
          -  Participants with dry mouth syndrome or burning mouth syndrome or menopausal women&#xD;
             suffering from dysgeusia.&#xD;
&#xD;
          -  Participants who have acute gastrointestinal (GI) symptoms at screening or admission&#xD;
             (e.g. nausea, vomiting, diarrhea, and heartburn).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Shire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PPD Development, LP</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5facfd1e17465c002989a19b</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <results_first_submitted>August 27, 2021</results_first_submitted>
  <results_first_submitted_qc>February 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2022</results_first_posted>
  <last_update_submitted>February 5, 2022</last_update_submitted>
  <last_update_submitted_qc>February 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maribavir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04497883/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04497883/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at single center in the United States from 07 Aug 2020 (first participant first visit) to 12 Nov 2020 (last participant last visit).</recruitment_details>
      <pre_assignment_details>A total of 24 participants (12 non-Hispanic Caucasian participants in Cohort A and 12 Japanese participants in Cohort B) were enrolled, randomized and received the study treatment in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort A: Non-Hispanic, Caucasian</title>
          <description>Non-Hispanic, Caucasian participants received single dose of 400 milligram (mg) maribavir tablets orally on Day 1 during treatment period 1.</description>
        </group>
        <group group_id="P2">
          <title>Cohort B: Japanese Descent: Maribavir 400mg</title>
          <description>Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
        </group>
        <group group_id="P3">
          <title>Cohort B: Japanese Descent: First Maribavir 200 mg Then Maribavir 800 mg</title>
          <description>Japanese descent participants who received 400 mg maribavir tablets during treatment period 1 received single dose of 200 mg maribavir tablet orally on Day 1 during treatment period 2 followed by single dose of 800 mg maribavir tablets orally on Day 1 during treatment period 3. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.</description>
        </group>
        <group group_id="P4">
          <title>Cohort B: Japanese Descent: First Maribavir 800 mg Then Maribavir 200 mg</title>
          <description>Japanese descent participants who received 400 mg maribavir tablets during treatment period 1 received single dose of 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 200 mg maribavir tablet orally on Day 1 during treatment period 3. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1 (2 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 1 (72 Hours)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 2 (2 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" 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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Washout Period 2 (72 Hours)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" 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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period 3 (2 Days)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" 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 group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The safety set consisted of participants who were administered at least 1 dose of maribavir and had at least 1 post-dose safety assessment.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort A: Non-Hispanic, Caucasian</title>
          <description>Non-Hispanic, Caucasian participants received 400 mg maribavir tablets orally once on Day 1 during treatment period 1.</description>
        </group>
        <group group_id="B2">
          <title>Cohort B: Japanese Descent</title>
          <description>Japanese descent participants received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.</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="12"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="24"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.3" spread="9.33"/>
                    <measurement group_id="B2" value="40.8" spread="8.92"/>
                    <measurement group_id="B3" value="40.0" spread="8.95"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="20"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </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="0"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="12"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of Maribavir</title>
        <description>Cmax of maribavir in plasma were reported.</description>
        <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
        <population>The pharmacokinetic (PK) set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Maribavir 400 mg</title>
            <description>Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Maribavir 400 mg</title>
            <description>Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Maribavir 200 mg</title>
            <description>Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: Maribavir 800 mg</title>
            <description>Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of Maribavir</title>
          <description>Cmax of maribavir in plasma were reported.</description>
          <population>The pharmacokinetic (PK) set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.</population>
          <units>Micrograms per milliliter (mcg/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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.8" spread="26.6"/>
                    <measurement group_id="O2" value="17.4" spread="27.4"/>
                    <measurement group_id="O3" value="9.03" spread="34.0"/>
                    <measurement group_id="O4" value="26.3" spread="30.7"/>
                  </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>
            <groups_desc>The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.</non_inferiority_desc>
            <param_type>% Ratio of Geometric least square means</param_type>
            <param_value>110.41</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>91.70</ci_lower_limit>
            <ci_upper_limit>132.94</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir</title>
        <description>AUClast of maribavir in plasma were reported.</description>
        <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
        <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Maribavir 400 mg</title>
            <description>Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Maribavir 400 mg</title>
            <description>Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Maribavir 200 mg</title>
            <description>Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: Maribavir 800 mg</title>
            <description>Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir</title>
          <description>AUClast of maribavir in plasma were reported.</description>
          <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.</population>
          <units>Hour*microgram per milliliter (h*mcg/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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.3" spread="33.6"/>
                    <measurement group_id="O2" value="92.3" spread="35.3"/>
                    <measurement group_id="O3" value="41.3" spread="40.8"/>
                    <measurement group_id="O4" value="183" spread="40.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.</non_inferiority_desc>
            <param_type>% Ratio of Geometric least square means</param_type>
            <param_value>122.49</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>96.83</ci_lower_limit>
            <ci_upper_limit>154.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir</title>
        <description>AUC(0-infinity) of maribavir in plasma were reported.</description>
        <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
        <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Maribavir 400 mg</title>
            <description>Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Maribavir 400 mg</title>
            <description>Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Maribavir 200 mg</title>
            <description>Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: Maribavir 800 mg</title>
            <description>Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir</title>
          <description>AUC(0-infinity) of maribavir in plasma were reported.</description>
          <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data.</population>
          <units>h*mcg/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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.3" spread="34.7"/>
                    <measurement group_id="O2" value="96.7" spread="37.1"/>
                    <measurement group_id="O3" value="43.0" spread="42.4"/>
                    <measurement group_id="O4" value="195" spread="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The comparison analysis was planned between Cohort A: Maribavir 400 mg and Cohort B: Maribavir 400 mg group participants only.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Analysis was performed with Equivalence Acceptance Range for 90% Confidence Interval (CI) as 80.00% - 125.00%.</non_inferiority_desc>
            <param_type>% Ratio of Geometric least square means</param_type>
            <param_value>125.08</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>97.99</ci_lower_limit>
            <ci_upper_limit>159.64</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants</title>
        <description>Dose proportionality was assessed using the power model including log-transformed Cmax dependent variable and the log-transformed dose as a fixed effect. Natural log (ln) and 90% confidence interval for the slope are presented.</description>
        <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
        <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of Cmax of maribavir was planned to be evaluated in Japanese descent participants only.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Japanese Descent</title>
            <description>All Japanese descent participants who received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants</title>
          <description>Dose proportionality was assessed using the power model including log-transformed Cmax dependent variable and the log-transformed dose as a fixed effect. Natural log (ln) and 90% confidence interval for the slope are presented.</description>
          <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of Cmax of maribavir was planned to be evaluated in Japanese descent participants only.</population>
          <units>ln (Cmax [mcg/mL])</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</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="0.771" lower_limit="0.62" upper_limit="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants</title>
        <description>Dose proportionality was assessed using the power model including log-transformed AUClast dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.</description>
        <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
        <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of AUClast of maribavir was planned to be evaluated in Japanese descent participants only.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Japanese Descent</title>
            <description>All Japanese descent participants who received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants</title>
          <description>Dose proportionality was assessed using the power model including log-transformed AUClast dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.</description>
          <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of AUClast of maribavir was planned to be evaluated in Japanese descent participants only.</population>
          <units>ln (AUClast[h*mcg/mL])</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</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="1.07" lower_limit="0.89" upper_limit="1.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants</title>
        <description>Dose proportionality was assessed using the power model including log-transformed AUC0-inifinity dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.</description>
        <time_frame>Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose</time_frame>
        <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of AUC0-infinity of maribavir was planned to be evaluated in Japanese descent participants only.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort B: Japanese Descent</title>
            <description>All Japanese descent participants who received single dose of 400 mg maribavir tablets orally on Day 1 during treatment period 1 followed by single dose of 200 mg or 800 mg maribavir tablets orally on Day 1 during treatment period 2 followed by single dose of 800 mg or 200 mg maribavir tablets orally on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours was maintained between treatment period 1, 2, and 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants</title>
          <description>Dose proportionality was assessed using the power model including log-transformed AUC0-inifinity dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.</description>
          <population>The PK set consisted of participants who received at least 1 dose of maribavir and had evaluable post-dose maribavir PK data. Dose proportionality of AUC0-infinity of maribavir was planned to be evaluated in Japanese descent participants only.</population>
          <units>ln (AUC0-infnity[h*mcg/mL])</units>
          <param>Number</param>
          <dispersion>90% Confidence Interval</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="1.09" lower_limit="0.90" upper_limit="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs</title>
        <description>An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this investigational product (IP) or medicinal product. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported in both non-Hispanic, Caucasian and Japanese descent participants.</description>
        <time_frame>From start of study drug administration to follow-up (up to Day 23)</time_frame>
        <population>The safety set consisted of participants who were administered at least 1 dose of maribavir and had at least 1 post-dose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: Maribavir 400 mg</title>
            <description>Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Maribavir 400 mg</title>
            <description>Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
          </group>
          <group group_id="O3">
            <title>Cohort B: Maribavir 200 mg</title>
            <description>Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
          </group>
          <group group_id="O4">
            <title>Cohort B: Maribavir 800 mg</title>
            <description>Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs</title>
          <description>An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this investigational product (IP) or medicinal product. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported in both non-Hispanic, Caucasian and Japanese descent participants.</description>
          <population>The safety set consisted of participants who were administered at least 1 dose of maribavir and had at least 1 post-dose safety assessment.</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="12"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with serious TEAEs</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_list>

    <reported_events>
      <time_frame>From start of study drug administration to follow-up (up to Day 23)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cohort A: Maribavir 400 mg</title>
          <description>Non-Hispanic, Caucasian participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
        </group>
        <group group_id="E2">
          <title>Cohort B: Maribavir 400 mg</title>
          <description>Japanese descent participants received single oral dose of 400 mg maribavir tablets on Day 1 during treatment period 1.</description>
        </group>
        <group group_id="E3">
          <title>Cohort B: Maribavir 200 mg</title>
          <description>Japanese descent participants received single oral dose of 200 mg maribavir tablets on Day 1 during treatment period 2 or 3.</description>
        </group>
        <group group_id="E4">
          <title>Cohort B: Maribavir 800 mg</title>
          <description>Japanese descent participants received single oral dose of 800 mg maribavir tablets on Day 1 during treatment period 2 or 3.</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="12"/>
                <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="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
                <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="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</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="4" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" 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="12"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <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="12"/>
              </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>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@takeda.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/NCT04497883
org study id: TAK-620-1020
nct id: NCT04497883
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to compare the pharmacokinetics (PK), safety, and tolerability
      of maribavir administered as a single oral dose in healthy, adult participants of Japanese
      descent and matched, healthy, adult, non-Hispanic, Caucasian participants. In addition, this
      study will assess the dose-proportionality of PK of maribavir in healthy, adult participants
      of Japanese descent.
The study will be conducted in two cohorts, Cohort A and Cohort B. Cohort A consists of 12
      participants of Japanese Descent. Cohort B consists of 12 non-Hispanic, Caucasian
      participants.

      For Japanese participants there will be three treatment periods. In Treatment Period 1, they
      will receive maribavir as a single 400 mg oral dose. In Treatment Periods 2 and 3, all
      Japanese participants will receive maribavir as a single oral dose of either 200 mg or 800
      mg, depending upon randomization assignment. For the non-Hispanic, Caucasian group there will
      be only one treatment period and they will receive maribavir as a single 400 mg oral dose.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax) of Maribavir
time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
description: Cmax of maribavir in plasma were reported.
measure: Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Maribavir
time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
description: AUClast of maribavir in plasma were reported.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-infinity) of Maribavir
time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
description: AUC(0-infinity) of maribavir in plasma were reported.
measure: Dose Proportionality of Cmax of Maribavir in Japanese Descent Participants
time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
description: Dose proportionality was assessed using the power model including log-transformed Cmax dependent variable and the log-transformed dose as a fixed effect. Natural log (ln) and 90% confidence interval for the slope are presented.
measure: Dose Proportionality of AUClast of Maribavir in Japanese Descent Participants
time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
description: Dose proportionality was assessed using the power model including log-transformed AUClast dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.
measure: Dose Proportionality of AUC0-infinity of Maribavir in Japanese Descent Participants
time frame: Day 1 of each treatment period: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 20, and 24 hours post-dose
description: Dose proportionality was assessed using the power model including log-transformed AUC0-inifinity dependent variable and the log-transformed dose as a fixed effect. ln and 90% confidence interval for the slope are presented.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
time frame: From start of study drug administration to follow-up (up to Day 23)
description: An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily had a causal relationship with this investigational product (IP) or medicinal product. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. A TEAE was any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. Number of Participants with TEAEs and serious TEAEs were reported in both non-Hispanic, Caucasian and Japanese descent participants.
arm group label: Cohort A: Non-Hispanic, Caucasian
arm group type: Experimental
description: Non-Hispanic, Caucasian group participants will receive 400 milligram (mg) maribavir tablets orally once on Day 1 during treatment period 1.
arm group label: Cohort B: Japanese Descent
arm group type: Experimental
description: Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1 followed by 200 mg or 800 mg maribavir tablets orally once on Day 1 during treatment period 2 followed by 800 mg or 200 mg maribavir tablets orally once on Day 1 during treatment period 3 in cross-over fashion. A washout period of 72 hours will be maintained between treatment period 1, 2, and 3.
intervention type: Drug
intervention name: Maribavir (400 mg)
description: Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.
arm group label: Cohort A: Non-Hispanic, Caucasian
arm group label: Cohort B: Japanese Descent
other name: SHP620
other name: TAK-620
intervention type: Drug
intervention name: Maribavir (200 mg)
description: Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.
arm group label: Cohort B: Japanese Descent
other name: SHP620
other name: TAK-620
intervention type: Drug
intervention name: Maribavir (800 mg)
description: Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.
arm group label: Cohort B: Japanese Descent
other name: SHP620
other name: TAK-620
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Study Director
role: Study Director
affiliation: Shire
facility: 
country: United States
url: https://clinicaltrials.takeda.com/study-detail/5facfd1e17465c002989a19b
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Maribavir
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 