<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/NCT03760276</url>
  </required_header>
  <id_info>
    <org_study_id>Voriconazole_CYP2C19</org_study_id>
    <nct_id>NCT03760276</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen</brief_title>
  <official_title>A Pilot Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen Based on the Population Pharmacokinetic Model and the Influence of Sex on the Pharmacokinetics of Voriconazole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A pilot study was performed to evaluate the appropriateness of the voriconazole dosing&#xD;
      regimen based on the population pharmacokinetic model and the influence of sex on the&#xD;
      pharmacokinetics of voriconazole&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2018</start_date>
  <completion_date type="Actual">October 28, 2018</completion_date>
  <primary_completion_date type="Actual">October 28, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak plasma concentration (Cmax)</measure>
    <time_frame>Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours</time_frame>
    <description>Pharmacokinetic sampling after administration of drugs from day 1 to day 7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast)</measure>
    <time_frame>Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours</time_frame>
    <description>Pharmacokinetic sampling after administration of drugs from day 1 to day 7</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genetic polymorphisms of CYP2C9 and CYP3A4</measure>
    <time_frame>Day 1 0 hour</time_frame>
    <description>Exploratory evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic safety marker of miRNA-122</measure>
    <time_frame>Day 1 0 hour, Day 5 12 hour, Day 7 12 hour</time_frame>
    <description>Exploratory safety evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examination (list of current medications)</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examination (list of any symptoms or pain)</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examination (Medical and surgical history)</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Vital signs (body temperature °C)</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Vital signs (blood pressure mmHg)</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Vital signs (pulse (heart rate, beats per minute))</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability evaluation by 12-lead ECG (P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval, U wave)</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants with abnormal laboratory values (hematologic, chemical, urine)</measure>
    <time_frame>Day 1 to Day 12</time_frame>
    <description>Safety and tolerability evaluation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Fungal Infection</condition>
  <arm_group>
    <arm_group_label>Voriconazole TBD mg tablet orally, every 12 hours for 7 days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Voriconazole Oral Product (Vfend®)</intervention_name>
    <description>To be determined mg of Voriconazole (Vfend®, anti-fungal agent)</description>
    <arm_group_label>Voriconazole TBD mg tablet orally, every 12 hours for 7 days</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Those who have been informed of the nature of the trial and have voluntarily agreed to&#xD;
             participate in this study and have signed an IRB approved consent before all screening&#xD;
             tests&#xD;
&#xD;
          -  Healthy Korean male and female volunteers aged 20 to 45&#xD;
&#xD;
          -  Those with a body weight of 50 kg or more and less than 90 kg and a body mass index&#xD;
             (BMI) of 18 or more and less than 27 (BMI(kg/m2) = body weight (kg)/{height(m)}2&#xD;
&#xD;
          -  CYP2C19 EM or PM&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with clinical evidence of significant respiratory, circulatory, renal,&#xD;
             hepatic, endocrine, blood, neuropsychiatric, skeletal or other chronic diseases,&#xD;
             alcohol or drug addiction&#xD;
&#xD;
          -  Subjects with a history of gastrointestinal disorders (Crohn's disease, ulcers, acute&#xD;
             or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal&#xD;
             surgery or hernia surgery) that may affect the absorption of the test drug&#xD;
&#xD;
          -  Those with a history of substance abuse within the last 2 months&#xD;
&#xD;
          -  Those who have taken any prescribed medicines or herbal medicines within 2 weeks prior&#xD;
             to the date of the first medicines, or those taking any general medicines (OTC) or&#xD;
             vitamin preparations (eligible if the other conditions are reasonable according to the&#xD;
             judgment of the investigator)&#xD;
&#xD;
          -  Those who donate blood within 30 days before the date of the first dose or who have&#xD;
             participated in the clinical study of other clinical trial drugs or marketed drugs&#xD;
             within 3 months&#xD;
&#xD;
          -  Those who have had significant adverse reactions such as hypersensitivity reactions to&#xD;
             azole drugs including drugs for clinical research&#xD;
&#xD;
          -  Those who are not planning on or planning to have a pregnancy during the trial and are&#xD;
             not able to use a recognized method of contraception (eg, sterilization surgery of the&#xD;
             person and partner, intrauterine contraceptive device, or diaphragm contraception&#xD;
             (such as diaphragm or condom use)&#xD;
&#xD;
          -  Persons who are continuously drinking (21 units / week, 1 unit = 10 g of pure alcohol)&#xD;
             or who can not abstain from 3 days before the first dose to the end of the clinical&#xD;
             trial&#xD;
&#xD;
          -  Those who smoked more than 10 cigarettes per day for the last 3 months or who can not&#xD;
             quit smoking 3 days before the first dose&#xD;
&#xD;
          -  Those who consume grapefruit / caffeine-containing food within 3 days of the first&#xD;
             dose or who cannot be prohibited during the clinical study period&#xD;
&#xD;
          -  Screening tests for urine pregnancy (β-hCG) positive or lactating women&#xD;
&#xD;
          -  Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or&#xD;
             glucose-galactose malabsorption.&#xD;
&#xD;
          -  A person who is found to be unsuitable for participation in clinical research due to&#xD;
             safety laboratory results or other reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital Clinical Trial Center</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>November 29, 2018</last_update_submitted>
  <last_update_submitted_qc>November 29, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>SeungHwan Lee</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Voriconazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03760276
org study id: Voriconazole_CYP2C19
nct id: NCT03760276
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
A pilot study was performed to evaluate the appropriateness of the voriconazole dosing
      regimen based on the population pharmacokinetic model and the influence of sex on the
      pharmacokinetics of voriconazole
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Peak plasma concentration (Cmax)
time frame: Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
description: Pharmacokinetic sampling after administration of drugs from day 1 to day 7
measure: Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast)
time frame: Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
description: Pharmacokinetic sampling after administration of drugs from day 1 to day 7
measure: Genetic polymorphisms of CYP2C9 and CYP3A4
time frame: Day 1 0 hour
description: Exploratory evaluation
measure: Hepatic safety marker of miRNA-122
time frame: Day 1 0 hour, Day 5 12 hour, Day 7 12 hour
description: Exploratory safety evaluation
measure: Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: Physical examination (list of current medications)
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: Physical examination (list of any symptoms or pain)
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: Physical examination (Medical and surgical history)
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: Evaluation of Vital signs (body temperature °C)
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: Evaluation of Vital signs (blood pressure mmHg)
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: Evaluation of Vital signs (pulse (heart rate, beats per minute))
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: Safety and tolerability evaluation by 12-lead ECG (P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval, U wave)
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
measure: number of participants with abnormal laboratory values (hematologic, chemical, urine)
time frame: Day 1 to Day 12
description: Safety and tolerability evaluation
arm group label: Voriconazole TBD mg tablet orally, every 12 hours for 7 days
arm group type: Experimental
intervention type: Drug
intervention name: Voriconazole Oral Product (Vfend®)
description: To be determined mg of Voriconazole (Vfend®, anti-fungal agent)
arm group label: Voriconazole TBD mg tablet orally, every 12 hours for 7 days
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: SeungHwan Lee
investigator title: Clinical Assistant Professor
mesh term: Mycoses
mesh term: Voriconazole
sharing ipd: No