<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/NCT03295266</url>
  </required_header>
  <id_info>
    <org_study_id>3866-006</org_study_id>
    <secondary_id>MK-3866-006</secondary_id>
    <nct_id>NCT03295266</nct_id>
  </id_info>
  <brief_title>Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)</brief_title>
  <official_title>An Open-Label Study to Investigate the Single-Dose Pharmacokinetics of MK-3866 When Administered to Subjects With Moderate and Severe Hepatic Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of&#xD;
      intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI)&#xD;
      compared to that of matched healthy participants. The primary purpose of this study is to&#xD;
      understand the effect of HI on the plasma PK of MK-3866 in order to guide dosing&#xD;
      recommendations for participants with HI. This study will also evaluate the safety and&#xD;
      tolerability of MK-3866 in participants with moderate and severe HI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Business and program changes&#xD;
  </why_stopped>
  <start_date type="Actual">December 19, 2017</start_date>
  <completion_date type="Actual">March 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 15, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)</measure>
    <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
    <description>AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)</measure>
    <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
    <description>AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)</measure>
    <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose</time_frame>
    <description>AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration at the End of Infusion (Ceoi) of MK-3866</measure>
    <time_frame>0.5 (end of infusion) hours postdose</time_frame>
    <description>The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Maximum Concentration (Tmax) of MK-3866</measure>
    <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
    <description>Tmax is the time at which the maximum plasma drug concentration is detected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Half-life (t1/2) of MK-3866</measure>
    <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
    <description>Apparent t1/2 is the elimination half-life of MK-3866 from plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance (CL) of MK-3866</measure>
    <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
    <description>CL is the volume of plasma from which the study drug is completely removed per unit time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution (Vz) of MK-3866</measure>
    <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
    <description>Vz is the apparent volume of distribution during the terminal phase.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)</measure>
    <time_frame>Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose</time_frame>
    <description>Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Clearance (CLr) of MK-3866</measure>
    <time_frame>Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose</time_frame>
    <description>CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Adverse Event (AE)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued the Study Due to an AE</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Hepatic Insufficiency</condition>
  <condition>Antibacterial Agents</condition>
  <arm_group>
    <arm_group_label>Moderate Hepatic Impairment (Panel A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with moderate HI (estimated glomerular filtration rate [eGFR] of ≤60mL/min/1.73m^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe Hepatic Impairment (Panel B)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Matched Controls (Panel C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy participants receive a single IV dose of MK-3866 (150 mg) on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MK-3866</intervention_name>
    <description>Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.</description>
    <arm_group_label>Healthy Matched Controls (Panel C)</arm_group_label>
    <arm_group_label>Moderate Hepatic Impairment (Panel A)</arm_group_label>
    <arm_group_label>Severe Hepatic Impairment (Panel B)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index ≥19 &amp; ≤40 kg/m^2&#xD;
&#xD;
          -  Continuous non-smoker prior to screening &amp; enrollment&#xD;
&#xD;
          -  HI Participants: Baseline health judged to be stable based on medical history (except&#xD;
             for the HI condition), physical examination, vital signs, electrocardiograms, &amp;&#xD;
             laboratory safety tests&#xD;
&#xD;
          -  Healthy control participants: Is medically healthy with no clinically significant&#xD;
             medical history, physical examination, laboratory profiles, vital signs, or&#xD;
             electrocardiograms&#xD;
&#xD;
          -  HI Participants: Diagnosis of chronic (&gt;6 months), stable (no acute episodes of&#xD;
             illness within the previous 2 months due to deterioration in hepatic function) HI with&#xD;
             features of cirrhosis&#xD;
&#xD;
          -  HI Participants - Panel A (moderate HI) only: score on the Child-Pugh scale from 7 to&#xD;
             9 (moderate HI). At least 3 participants must have a score of 2 or higher on at least&#xD;
             one of the laboratory parameters (i.e., albumin, international normalized ratio,&#xD;
             and/or bilirubin) on the Child-Pugh scale&#xD;
&#xD;
          -  HI Participants - Panel B (severe HI) only: Score on the Child-Pugh scale from 10 to&#xD;
             15 (severe HI)&#xD;
&#xD;
          -  Is completely informed of the unknown risks of pregnancy &amp; agrees not to become&#xD;
             pregnant or father a child during time in study&#xD;
&#xD;
          -  For a female of childbearing potential: is either sexually inactive (abstinent) for 14&#xD;
             days prior to dosing &amp; throughout the study or is using an acceptable birth control&#xD;
             method&#xD;
&#xD;
          -  Non-vasectomized male: Participants must agree to use a condom with spermicide or&#xD;
             abstain from sexual intercourse from dosing until 90 days after dosing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mentally or legally incapacitated or has significant emotional problems at the time of&#xD;
             the screening visit or expected during the conduct of the study&#xD;
&#xD;
          -  Has a history or presence of clinically significant medical or psychiatric condition&#xD;
             or disease (other than HI - Panels A &amp; B) that might confound the results of the study&#xD;
             or poses an additional risk to the participant. Remote history of cholecystectomy that&#xD;
             is not an active issue may be included.&#xD;
&#xD;
          -  Panels A &amp; B: Has a clinically significant history of cancer. Remote history with full&#xD;
             cure or limited disease with complete resection (cure) may be included&#xD;
&#xD;
          -  Has a history of drug/alcohol abuse within the past 6 months prior to dosing (Panels A&#xD;
             &amp; B) or within the past 2 years prior to dosing (Panel C [Healthy controls])&#xD;
&#xD;
          -  Panels A &amp; B: Consumes more than 3 glasses of alcoholic beverages (1 glass&#xD;
             approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces], or&#xD;
             distilled spirits [29.5 mL/1 ounce]) per day, within 6 months of screening.&#xD;
             Participants that consume 4 glasses of alcoholic beverages/day may be enrolled&#xD;
&#xD;
          -  Panels A &amp; B: Consumes excessive amounts, defined as more than 6 servings (1 serving&#xD;
             approximately equivalent to 120 mg of caffeine), of coffee, tea, cola, energy-drinks,&#xD;
             or other caffeinated beverages/day&#xD;
&#xD;
          -  Panels A &amp; B: Has a history of a liver transplant&#xD;
&#xD;
          -  Has a history or presence of hypersensitivity or idiosyncratic reaction to the study&#xD;
             drugs or related compounds&#xD;
&#xD;
          -  Has moderate or severe renal insufficiency (estimated glomerular filtration rate of&#xD;
             ≤60 mL/min/1.73 m2 for moderate HI or healthy control participants or ≤50 mL/min/1.73&#xD;
             m2 for severe HI participants)&#xD;
&#xD;
          -  Panel C: Has positive macroscopic urine protein at screening (trace protein by&#xD;
             dipstick allowed)&#xD;
&#xD;
          -  Is a female participant who is pregnant or lactating&#xD;
&#xD;
          -  Has positive results for the urine or breath alcohol screen and/or urine drug screen&#xD;
             at screening&#xD;
&#xD;
          -  Has positive results at screening for human immunodeficiency virus (HIV) (Panels A &amp;&#xD;
             B) or for HIV, HBsAg, or hepatitis C virus (HCV) (Panel C)&#xD;
&#xD;
          -  Panels A &amp; B: Participants with active HCV infection or hepatitis B virus (HBV)&#xD;
             infection. Participants with prior/inactive HCV infection or past HBV infection may be&#xD;
             enrolled.&#xD;
&#xD;
          -  Is unable to refrain from or anticipates use of any medication or substance prohibited&#xD;
             in study&#xD;
&#xD;
          -  Has taken amiodarone at any time in their life&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Merck Sharp &amp; Dohme LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology of Miami ( Site 0001)</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Clinical Research Center ( Site 0002)</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <results_first_submitted>October 22, 2019</results_first_submitted>
  <results_first_submitted_qc>October 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 13, 2019</results_first_posted>
  <last_update_submitted>October 22, 2019</last_update_submitted>
  <last_update_submitted_qc>October 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatic Insufficiency</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf</ipd_description>
    <ipd_url>http://engagezone.msd.com/ds_documentation.php</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/66/NCT03295266/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study terminated prior to enrollment of any healthy control participants.</recruitment_details>
      <pre_assignment_details>Participants with moderate or severe hepatic impairment (HI) based on estimated glomerular filtration rate (eGFR) were enrolled at 2 study centers in the US.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Moderate Hepatic Impairment (Panel A)</title>
          <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Severe Hepatic Impairment (Panel B)</title>
          <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
              </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>Moderate Hepatic Impairment (Panel A)</title>
          <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Severe Hepatic Impairment (Panel B)</title>
          <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="9"/>
          </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="60.0" spread="5.96"/>
                    <measurement group_id="B2" value="56.0" spread="8.98"/>
                    <measurement group_id="B3" value="58.2" spread="7.24"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>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>Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)</title>
        <description>AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.</description>
        <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
        <population>All treated participants with data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)</title>
          <description>AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.</description>
          <population>All treated participants with data available are included.</population>
          <units>hour*µM</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4" spread="7.3"/>
                    <measurement group_id="O2" value="58.6" spread="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)</title>
        <description>AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.</description>
        <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
        <population>All treated participants with data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)</title>
          <description>AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.</description>
          <population>All treated participants with data available are included.</population>
          <units>hour*µM</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.7" spread="7.4"/>
                    <measurement group_id="O2" value="57.9" spread="42.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)</title>
        <description>AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.</description>
        <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose</time_frame>
        <population>All treated participants with data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)</title>
          <description>AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.</description>
          <population>All treated participants with data available are included.</population>
          <units>hour*µM</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="5"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.6" spread="7.5"/>
                    <measurement group_id="O2" value="54.6" spread="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Concentration at the End of Infusion (Ceoi) of MK-3866</title>
        <description>The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.</description>
        <time_frame>0.5 (end of infusion) hours postdose</time_frame>
        <population>All treated participants with data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration at the End of Infusion (Ceoi) of MK-3866</title>
          <description>The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.</description>
          <population>All treated participants with data available are included.</population>
          <units>µM</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" spread="22.0"/>
                    <measurement group_id="O2" value="11.0" spread="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Maximum Concentration (Tmax) of MK-3866</title>
        <description>Tmax is the time at which the maximum plasma drug concentration is detected.</description>
        <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
        <population>All treated participants with data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Concentration (Tmax) of MK-3866</title>
          <description>Tmax is the time at which the maximum plasma drug concentration is detected.</description>
          <population>All treated participants with data available are included.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" lower_limit="0.47" upper_limit="0.53"/>
                    <measurement group_id="O2" value="0.50" lower_limit="0.47" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Terminal Half-life (t1/2) of MK-3866</title>
        <description>Apparent t1/2 is the elimination half-life of MK-3866 from plasma.</description>
        <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
        <population>All treated participants with data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Half-life (t1/2) of MK-3866</title>
          <description>Apparent t1/2 is the elimination half-life of MK-3866 from plasma.</description>
          <population>All treated participants with data available are included.</population>
          <units>hours</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.54" spread="13.3"/>
                    <measurement group_id="O2" value="6.02" spread="4.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clearance (CL) of MK-3866</title>
        <description>CL is the volume of plasma from which the study drug is completely removed per unit time.</description>
        <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
        <population>All treated participants with data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance (CL) of MK-3866</title>
          <description>CL is the volume of plasma from which the study drug is completely removed per unit time.</description>
          <population>All treated participants with data available are included.</population>
          <units>Liters/hour</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.16" spread="7.3"/>
                    <measurement group_id="O2" value="5.07" spread="41.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Volume of Distribution (Vz) of MK-3866</title>
        <description>Vz is the apparent volume of distribution during the terminal phase.</description>
        <time_frame>Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose</time_frame>
        <population>All treated participants with data available are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution (Vz) of MK-3866</title>
          <description>Vz is the apparent volume of distribution during the terminal phase.</description>
          <population>All treated participants with data available are included.</population>
          <units>Liters</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="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.3" spread="15.8"/>
                    <measurement group_id="O2" value="44.0" spread="27.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)</title>
        <description>Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.</description>
        <time_frame>Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose</time_frame>
        <population>Urine samples were collected but were not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)</title>
          <description>Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.</description>
          <population>Urine samples were collected but were not analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Clearance (CLr) of MK-3866</title>
        <description>CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.</description>
        <time_frame>Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose</time_frame>
        <population>Urine samples were collected but were not analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance (CLr) of MK-3866</title>
          <description>CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.</description>
          <population>Urine samples were collected but were not analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One Adverse Event (AE)</title>
        <description>An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>Up to 14 days</time_frame>
        <population>All treated participants are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Adverse Event (AE)</title>
          <description>An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>All treated participants are included.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued the Study Due to an AE</title>
        <description>An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
        <time_frame>Up to 14 days</time_frame>
        <population>All treated participants are included.</population>
        <group_list>
          <group group_id="O1">
            <title>Moderate Hepatic Impairment (Panel A)</title>
            <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Severe Hepatic Impairment (Panel B)</title>
            <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued the Study Due to an AE</title>
          <description>An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.</description>
          <population>All treated participants are included.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 14 days</time_frame>
      <desc>All treated participants are included.</desc>
      <group_list>
        <group group_id="E1">
          <title>Moderate Hepatic Impairment (Panel A)</title>
          <description>Participants with moderate HI (eGFR of ≤60mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Severe Hepatic Impairment (Panel B)</title>
          <description>Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) received a single IV dose of MK-3866 (150 mg infused over 30 minutes) on Day 1.</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </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>The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Vice President, Global Clinical Development</name_or_title>
      <organization>Merck Sharp &amp; Dohme Corp.</organization>
      <phone>1-800-672-6372</phone>
      <email>ClinicalTrialsDisclosure@merck.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/NCT03295266
org study id: 3866-006
secondary id: MK-3866-006
nct id: NCT03295266
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of
      intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI)
      compared to that of matched healthy participants. The primary purpose of this study is to
      understand the effect of HI on the plasma PK of MK-3866 in order to guide dosing
      recommendations for participants with HI. This study will also evaluate the safety and
      tolerability of MK-3866 in participants with moderate and severe HI.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Concentration-time Curve of MK-3866 From Time 0 to Infinity (AUC0-∞)
time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
description: AUC0-∞ is determined for the period up to 72 hours post-single dose. AUC0-∞ is an estimate of total plasma exposure from dosing to (extrapolated) infinity.
measure: Area Under the Concentration-time Curve of MK-3866 From Time 0 to Last Quantifiable Concentration (AUC0-last)
time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
description: AUC0-last is determined for the period up to 72 hours post-single dose. AUC0-last is an estimate of total plasma exposure from dosing to the time of last measurable sample.
measure: Area Under the Concentration-time Curve of MK-3866 From Time 0 to 24 Hours (AUC0-24hr)
time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, and 24 hours postdose
description: AUC0-24 is determined for the period up to 24 hours post-single dose. AUC0-24 is an estimate of total daily plasma exposure from dosing to 24 hours postdose.
measure: Concentration at the End of Infusion (Ceoi) of MK-3866
time frame: 0.5 (end of infusion) hours postdose
description: The plasma sample collected at end-of-infusion (0.5 hours postdose) was used to determine Ceoi.
measure: Time to Maximum Concentration (Tmax) of MK-3866
time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
description: Tmax is the time at which the maximum plasma drug concentration is detected.
measure: Apparent Terminal Half-life (t1/2) of MK-3866
time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
description: Apparent t1/2 is the elimination half-life of MK-3866 from plasma.
measure: Clearance (CL) of MK-3866
time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
description: CL is the volume of plasma from which the study drug is completely removed per unit time.
measure: Volume of Distribution (Vz) of MK-3866
time frame: Predose, 0.5 (end of infusion), 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, 12, 24, 48, and 72 hours postdose
description: Vz is the apparent volume of distribution during the terminal phase.
measure: Fraction of Dose of MK-3866 Excreted Unchanged in Urine (Fe)
time frame: Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose
description: Fe is the amount of drug excreted unchanged in urine. Urine samples were collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.
measure: Renal Clearance (CLr) of MK-3866
time frame: Predose, then pooled in the following increments: 0-4, 4-8, 8-12, 12-24 hours postdose
description: CLr is the volume of plasma from which the study drug is completely removed per unit time by the kidney (i.e., excreted into the urine). Urine samples are collected in 4-hour intervals up to 24 hours post-dose. The study terminated prior to analysis of urine samples and therefore no data are available.
measure: Number of Participants With at Least One Adverse Event (AE)
time frame: Up to 14 days
description: An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
measure: Number of Participants Who Discontinued the Study Due to an AE
time frame: Up to 14 days
description: An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
arm group label: Moderate Hepatic Impairment (Panel A)
arm group type: Experimental
description: Participants with moderate HI (estimated glomerular filtration rate [eGFR] of ≤60mL/min/1.73m^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.
arm group label: Severe Hepatic Impairment (Panel B)
arm group type: Experimental
description: Participants with severe HI (eGFR of ≤50 mL/min/1.73m^2) receive a single IV dose of MK-3866 (150 mg) on Day 1.
arm group label: Healthy Matched Controls (Panel C)
arm group type: Experimental
description: Healthy participants receive a single IV dose of MK-3866 (150 mg) on Day 1.
intervention type: Drug
intervention name: MK-3866
description: Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.
arm group label: Healthy Matched Controls (Panel C)
arm group label: Moderate Hepatic Impairment (Panel A)
arm group label: Severe Hepatic Impairment (Panel B)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Merck Sharp & Dohme LLC
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hepatic Insufficiency
mesh term: Liver Failure
sharing ipd: Yes
ipd description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
ipd url: http://engagezone.msd.com/ds_documentation.php
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 