<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/NCT04482270</url>
  </required_header>
  <id_info>
    <org_study_id>2693-CL-0007</org_study_id>
    <nct_id>NCT04482270</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function</brief_title>
  <official_title>A Phase 1 Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Fezolinetant Compared to Subjects With Normal Hepatic Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Global Development, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of&#xD;
      fezolinetant and ES259564 (fezolinetant metabolite) in female participants with mild and&#xD;
      moderate hepatic impairment compared to healthy female participants with normal hepatic&#xD;
      function.&#xD;
&#xD;
      This study will also evaluate the safety and tolerability of a single oral dose of&#xD;
      fezolinetant in female participants with mild and moderate hepatic impairment and healthy&#xD;
      female participants with normal hepatic function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will comprise of three groups based on hepatic function. Participants will be&#xD;
      screened for up to 28 days prior to investigational product (IP) administration on Day 1.&#xD;
      Eligible participants will be admitted to the clinical unit on Day -1 and will be residential&#xD;
      for a single period of six days/five nights. On Day 1, participants will receive a single&#xD;
      oral dose of fezolinetant under fasting conditions followed by a 96-hour in-house blood and&#xD;
      urine sampling period. Participants are to remain semirecumbent for four hours postdose.&#xD;
      Standard safety and tolerability assessments will be conducted. Participants will be&#xD;
      discharged from the clinical unit on Day 5 on the condition that all required assessments&#xD;
      have been performed and that there are no medical reasons for a longer stay in the clinical&#xD;
      unit.&#xD;
&#xD;
      The study will be completed with an end-of-study visit (ESV). The ESV will take place five to&#xD;
      nine days after the last pharmacokinetic sample is collected or at the time of early&#xD;
      discontinuation from the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Actual">March 22, 2021</completion_date>
  <primary_completion_date type="Actual">March 22, 2021</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>Pharmacokinetics (PK) of Fezolinetant in Plasma: Area Under the Concentration-time Curve (AUC) From the Time of Dosing Extrapolated to Time Infinity (AUCinf)</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>AUCinf will be recorded from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of Fezolinetant in Plasma: AUC From the Time of Dosing to the Last Measurable Concentration (AUClast)</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>AUClast will be recorded from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of Fezolinetant in Plasma: Maximum Concentration (Cmax)</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>Cmax will be recorded from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of Fezolinetant in Plasma: Apparent Clearance (CL/F)</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>CL/F will be recorded from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of Fezolinetant in Plasma: Apparent volume of Distribution During Terminal Phase After Non-intravenous Administration (Vz/F)</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>Vz/F will be recorded from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of Fezolinetant Metabolite ES259564 in Plasma: AUCinf</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>AUCinf will be recorded from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of Fezolinetant Metabolite ES259564 in Plasma: AUClast</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>AUClast will be recorded from the PK plasma samples collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK of Fezolinetant Metabolite ES259564 in Plasma: Cmax</measure>
    <time_frame>Up to 5 days</time_frame>
    <description>Cmax will be recorded from the PK plasma samples collected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an IP and which does not necessarily have to have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Number of participants with potentially clinically significant laboratory values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Number of participants with potentially clinically significant vital sign values.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Number of participants with potentially clinically significant 12-lead ECG values.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Hepatic Impairment</condition>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Fezolinetant: Mild Hepatic Impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fezolinetant: Moderate Hepatic Impairment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fezolinetant: Normal Hepatic Function</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fezolinetant</intervention_name>
    <description>Oral</description>
    <arm_group_label>Fezolinetant: Mild Hepatic Impairment</arm_group_label>
    <arm_group_label>Fezolinetant: Moderate Hepatic Impairment</arm_group_label>
    <arm_group_label>Fezolinetant: Normal Hepatic Function</arm_group_label>
    <other_name>ESN364</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has a Body Mass Index (BMI) range of 18.5 to 36.0 kg/m^2, inclusive and weighs&#xD;
             at least 50 kg at screening.&#xD;
&#xD;
          -  Female subject is not pregnant and at least one of the following conditions apply:&#xD;
&#xD;
               -  Not a woman of childbearing potential (WOCBP)&#xD;
&#xD;
               -  WOCBP who agrees to follow the contraceptive guidance for at least 30 days prior&#xD;
                  to day -1 through at least 30 days after IP administration.&#xD;
&#xD;
          -  Female subject must agree not to breastfeed starting at screening and throughout the&#xD;
             study period and for 30 days after IP administration.&#xD;
&#xD;
          -  Female subject must not donate ova starting at first dose of IP and throughout the&#xD;
             study period and for 30 days after IP administration.&#xD;
&#xD;
          -  Subject agrees not to participate in another interventional study while participating&#xD;
             in the present study.&#xD;
&#xD;
        Additional Criterion for Subjects with Hepatic Impairment:&#xD;
&#xD;
          -  Subject has mild (Child-Pugh classification Class A, score 5 or 6) or moderate&#xD;
             (Child-Pugh classification Class B, score 7 to 9) hepatic impairment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has received any investigational therapy within 28 days or five half-lives,&#xD;
             whichever is longer, prior to Day -1.&#xD;
&#xD;
          -  Subject has any condition which makes the subject unsuitable for study participation.&#xD;
&#xD;
          -  Female subject who has been pregnant within six months prior to screening or&#xD;
             breastfeeding within three months prior to screening.&#xD;
&#xD;
          -  Subject has a known or suspected hypersensitivity to fezolinetant or any components of&#xD;
             the formulation used.&#xD;
&#xD;
          -  Subject has had previous exposure with fezolinetant.&#xD;
&#xD;
          -  Subject has used any inducer of cytochrome P450 (CYP) 1A2 in the three months prior or&#xD;
             inhibitors of CYP 1A2 in the two weeks or five half-lives of the inhibitor, whichever&#xD;
             is longer, prior to Day -1.&#xD;
&#xD;
          -  Subject has any clinically significant history of allergic conditions (including drug&#xD;
             allergies, asthma, eczema or anaphylactic reactions, but excluding untreated,&#xD;
             asymptomatic, seasonal allergies) prior to IP administration.&#xD;
&#xD;
          -  Subject has/had febrile illness or symptomatic, viral (excluding chronic hepatitis B&#xD;
             and C), bacterial (including upper respiratory infection) or fungal (noncutaneous)&#xD;
             infection within one week prior to Day -1.&#xD;
&#xD;
          -  Subject has smoked, used tobacco-containing products and nicotine or&#xD;
             nicotine-containing products (e.g., electronic vapes) within six months prior to&#xD;
             screening or the subject tests positive for cotinine at screening or on Day -1.&#xD;
&#xD;
          -  Subject has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or&#xD;
             donated plasma within seven days prior to Day -1 and/or received a transfusion of any&#xD;
             blood or blood products within 60 days.&#xD;
&#xD;
          -  Subject is an employee of Astellas, the study-related contract research organizations&#xD;
             (CROs) or the clinical unit.&#xD;
&#xD;
          -  Subject has creatinine level outside normal limits on Day -1. In such a case, the&#xD;
             assessment may be repeated once.&#xD;
&#xD;
        Additional Criteria for Subjects with Hepatic Impairment:&#xD;
&#xD;
          -  Subject has any history or evidence of any clinically significant cardiovascular,&#xD;
             gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, dermatologic,&#xD;
             psychiatric, renal and/or other major disease or malignancy, not related to current&#xD;
             disease state.&#xD;
&#xD;
          -  Subject has a history of consuming &gt; 7 units of alcoholic beverages per week within&#xD;
             three months prior to screening or has a history of alcoholism or&#xD;
             drug/chemical/substance abuse within one year prior to screening (note: 1 unit = 12&#xD;
             ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the subject tests&#xD;
             positive for alcohol at screening or on Day -1.&#xD;
&#xD;
          -  Subject has a mean pulse &lt; 45 or &gt; 90 beats per minute (bpm); mean systolic blood&#xD;
             pressure (SBP) &gt; 160 millimeters of mercury (mmHg); mean diastolic blood pressure&#xD;
             (DBP) &gt; 100 mmHg (measurements taken in triplicate after subject has been resting in&#xD;
             the supine position for at least five minutes; pulse will be measured automatically)&#xD;
             on Day -1. If the mean blood pressure exceeds the limits above, one additional&#xD;
             triplicate may be taken.&#xD;
&#xD;
          -  Subject has a mean corrected QT interval using Fridericia's formula (QTcF) of &gt; 480&#xD;
             millisecond (msec) on Day -1. If the mean QTcF exceeds the limits above, one&#xD;
             additional triplicate electrocardiogram (ECG) may be taken.&#xD;
&#xD;
          -  Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines,&#xD;
             cannabinoids, cocaine and/or opiates) within three months prior to Day -1 or the&#xD;
             subject tests positive for drugs of abuse (amphetamines, barbiturates,&#xD;
             benzodiazepines, cannabinoids, cocaine and opiates) at screening or on Day -1, unless&#xD;
             the positive test is due to prescription drug use that is approved by the principal&#xD;
             investigator and sponsor.&#xD;
&#xD;
          -  Subject has a positive serology test for hepatitis A virus (HAV) antibodies&#xD;
             (immunoglobulin M [IgM]) or antibodies to human immunodeficiency virus (HIV) type 1&#xD;
             and/or type 2 at screening.&#xD;
&#xD;
          -  Subject has fluctuating or rapidly deteriorating hepatic function, as indicated by&#xD;
             strongly varying or worsening of clinical and/or laboratory signs of hepatic&#xD;
             impairment within the screening period (e.g., advanced ascites, infection of ascites,&#xD;
             fever, active gastrointestinal bleeding).&#xD;
&#xD;
          -  Subject who has had a change in dose regimen of medically required medication(s) in&#xD;
             the two weeks prior to screening (permitted concomitant medications) and/or subject&#xD;
             for whom dose changes are likely to occur during the study (minor dose changes are&#xD;
             allowed in agreement with the sponsor) and/or subject has used nonpermitted&#xD;
             concomitant medication(s) in the three weeks prior to admission to the clinical unit&#xD;
             (nonpermitted concomitant medications include any known hepatic enzyme-altering agents&#xD;
             or compounds known to restrict metabolism, vitamins, hormonal contraceptives, hormone&#xD;
             replacement therapy [HRT] and natural and herbal remedies, e.g., St. John's Wort).&#xD;
&#xD;
          -  Subject has a presence of a hepatocellular carcinoma, or an acute liver disease caused&#xD;
             by an infection or drug toxicity.&#xD;
&#xD;
          -  Subject has severe portal hypertension or surgical portosystemic shunts, including&#xD;
             transjugular intrahepatic portosystemic shunt.&#xD;
&#xD;
          -  Subject has biliary liver cirrhosis, biliary obstruction or other cause of hepatic&#xD;
             impairment not related to parenchymal disorder and/or disease of the liver.&#xD;
&#xD;
          -  Subject has signs of significant hepatic encephalopathy (hepatic encephalopathy Grade&#xD;
             ≥ 2).&#xD;
&#xD;
          -  Subject has severe ascites and/or pleural effusion.&#xD;
&#xD;
          -  Subject has esophageal/gastric variceal bleeding in the past six months prior to&#xD;
             screening, unless banded.&#xD;
&#xD;
          -  Subject has thrombocyte level below 40 × 10^9 per liter and /or hemoglobin &lt; 90 grams&#xD;
             per liter.&#xD;
&#xD;
          -  Subject has previous liver transplantation.&#xD;
&#xD;
        Additional Criteria for Healthy Subjects with Normal Hepatic Function:&#xD;
&#xD;
          -  Subject has any of the liver function tests (alkaline phosphatase [ALP], alanine&#xD;
             aminotransferase [ALT], aspartate aminotransferase [AST] and total bilirubin [TBL]) ≥&#xD;
             1.5 × the Upper Limit of Normal (ULN) or international normalized ratio (INR) &gt; 1.1 on&#xD;
             Day -1. In such a case, the assessment may be repeated once.&#xD;
&#xD;
          -  Subject has any history or evidence of any clinically significant cardiovascular,&#xD;
             gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,&#xD;
             urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major&#xD;
             disease or malignancy.&#xD;
&#xD;
          -  Subject has a history of consuming &gt; 7 units of alcoholic beverages per week within&#xD;
             six months prior to screening or has a history of alcoholism or&#xD;
             drug/chemical/substance abuse within two years prior to screening (note: 1 unit = 12&#xD;
             ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the subject tests&#xD;
             positive for alcohol at screening or on Day -1.&#xD;
&#xD;
          -  Subject has any clinically significant abnormality following the physical examination,&#xD;
             ECG and protocol-defined clinical laboratory tests at screening or on Day -1.&#xD;
&#xD;
          -  Subject has a mean pulse &lt; 45 or &gt; 90 bpm; mean SBP &gt; 140 mmHg; mean DBP &gt; 90 mmHg&#xD;
             (measurements taken in triplicate after subject has been resting in the supine&#xD;
             position for at least five minutes; pulse will be measured automatically) on Day -1.&#xD;
             If the mean blood pressure exceeds the limits above, one additional triplicate may be&#xD;
             taken.&#xD;
&#xD;
          -  Subject has a mean QTcF of &gt; 450 msec on Day -1. If the mean QTcF exceeds the limits&#xD;
             above, one additional triplicate ECG may be taken.&#xD;
&#xD;
          -  Subject has used any prescribed or nonprescribed drugs (including vitamins, hormonal&#xD;
             contraceptives, HRT and natural and herbal remedies, e.g., St. John's Wort) in the two&#xD;
             weeks prior to IP administration, except for occasional use of acetaminophen (up to 2&#xD;
             g/day) and topical dermatological products, including corticosteroid products.&#xD;
&#xD;
          -  Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines,&#xD;
             cannabinoids, cocaine and/or opiates) within three months prior to Day -1 or the&#xD;
             subject tests positive for drugs of abuse (amphetamines, barbiturates,&#xD;
             benzodiazepines, cannabinoids, cocaine and opiates) at screening or on Day -1.&#xD;
&#xD;
          -  Subject has a positive serology test for HAV antibodies (IgM), hepatitis B surface&#xD;
             antigen, hepatitis C virus antibodies or antibodies to HIV type 1 and/or type 2 at&#xD;
             screening.&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Executive Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Global Development, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research of West Florida, Inc.</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Pharmacology of Miami, LLC</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33014-361</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Research Corporation</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>72815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ES259564</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>fezolinetant</keyword>
  <keyword>Healthy Volunteers</keyword>
  <keyword>Hepatic Impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04482270
org study id: 2693-CL-0007
nct id: NCT04482270
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of
      fezolinetant and ES259564 (fezolinetant metabolite) in female participants with mild and
      moderate hepatic impairment compared to healthy female participants with normal hepatic
      function.

      This study will also evaluate the safety and tolerability of a single oral dose of
      fezolinetant in female participants with mild and moderate hepatic impairment and healthy
      female participants with normal hepatic function.
The study will comprise of three groups based on hepatic function. Participants will be
      screened for up to 28 days prior to investigational product (IP) administration on Day 1.
      Eligible participants will be admitted to the clinical unit on Day -1 and will be residential
      for a single period of six days/five nights. On Day 1, participants will receive a single
      oral dose of fezolinetant under fasting conditions followed by a 96-hour in-house blood and
      urine sampling period. Participants are to remain semirecumbent for four hours postdose.
      Standard safety and tolerability assessments will be conducted. Participants will be
      discharged from the clinical unit on Day 5 on the condition that all required assessments
      have been performed and that there are no medical reasons for a longer stay in the clinical
      unit.

      The study will be completed with an end-of-study visit (ESV). The ESV will take place five to
      nine days after the last pharmacokinetic sample is collected or at the time of early
      discontinuation from the study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pharmacokinetics (PK) of Fezolinetant in Plasma: Area Under the Concentration-time Curve (AUC) From the Time of Dosing Extrapolated to Time Infinity (AUCinf)
time frame: Up to 5 days
description: AUCinf will be recorded from the PK plasma samples collected.
measure: PK of Fezolinetant in Plasma: AUC From the Time of Dosing to the Last Measurable Concentration (AUClast)
time frame: Up to 5 days
description: AUClast will be recorded from the PK plasma samples collected.
measure: PK of Fezolinetant in Plasma: Maximum Concentration (Cmax)
time frame: Up to 5 days
description: Cmax will be recorded from the PK plasma samples collected.
measure: PK of Fezolinetant in Plasma: Apparent Clearance (CL/F)
time frame: Up to 5 days
description: CL/F will be recorded from the PK plasma samples collected.
measure: PK of Fezolinetant in Plasma: Apparent volume of Distribution During Terminal Phase After Non-intravenous Administration (Vz/F)
time frame: Up to 5 days
description: Vz/F will be recorded from the PK plasma samples collected.
measure: PK of Fezolinetant Metabolite ES259564 in Plasma: AUCinf
time frame: Up to 5 days
description: AUCinf will be recorded from the PK plasma samples collected.
measure: PK of Fezolinetant Metabolite ES259564 in Plasma: AUClast
time frame: Up to 5 days
description: AUClast will be recorded from the PK plasma samples collected.
measure: PK of Fezolinetant Metabolite ES259564 in Plasma: Cmax
time frame: Up to 5 days
description: Cmax will be recorded from the PK plasma samples collected.
measure: Number of Participants With Adverse Events (AEs)
time frame: Up to 14 days
description: AEs will be coded using Medical Dictionary for Regulatory Activities (MedDRA). An AE is any untoward medical occurrence in a participant administered an IP and which does not necessarily have to have a causal relationship with this treatment.
measure: Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)
time frame: Up to 14 days
description: Number of participants with potentially clinically significant laboratory values.
measure: Number of Participants With Vital Sign Abnormalities and/or Adverse Events (AEs)
time frame: Up to 14 days
description: Number of participants with potentially clinically significant vital sign values.
measure: Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)
time frame: Up to 14 days
description: Number of participants with potentially clinically significant 12-lead ECG values.
arm group label: Fezolinetant: Mild Hepatic Impairment
arm group type: Experimental
description: Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.
arm group label: Fezolinetant: Moderate Hepatic Impairment
arm group type: Experimental
description: Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.
arm group label: Fezolinetant: Normal Hepatic Function
arm group type: Experimental
description: Participants will receive a single oral dose of fezolinetant under fasting conditions on Day 1.
intervention type: Drug
intervention name: fezolinetant
description: Oral
arm group label: Fezolinetant: Mild Hepatic Impairment
arm group label: Fezolinetant: Moderate Hepatic Impairment
arm group label: Fezolinetant: Normal Hepatic Function
other name: ESN364
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Executive Medical Director
role: Study Director
affiliation: Astellas Pharma Global Development, Inc.
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."