<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/NCT03000218</url>
  </required_header>
  <id_info>
    <org_study_id>UDCA_overweight_LFTabnormal</org_study_id>
    <nct_id>NCT03000218</nct_id>
  </id_info>
  <brief_title>Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems</brief_title>
  <official_title>Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems</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>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are&#xD;
      overweight and have liver problems after ursodeoxycholic acid multiple administration&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has a randomized, open-label, three-treatment, one-sequence, placebo-controlled,&#xD;
      multiple drug administration design. The purpose of this study is as follows; To evaluate&#xD;
      pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver&#xD;
      problems after ursodeoxycholic acid administration&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid</measure>
    <time_frame>Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Low-density lipoprotein cholesterol at 8 weeks</measure>
    <time_frame>Day 1, 29, 57, 71 predose (0h)</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Overweight</condition>
  <condition>Abnormal Liver Function Tests</condition>
  <arm_group>
    <arm_group_label>UDCA 8 wks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 to 56: Ursodeoxycholic acid 300mg bid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UDCA for 4wks/UDCA+metformin for 4wks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Day 1 to 56: Placebo bid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ursodeoxycholic acid</intervention_name>
    <description>Ursodeoxycholic acid 300mg bid for 8 weeks</description>
    <arm_group_label>UDCA 8 wks</arm_group_label>
    <arm_group_label>UDCA for 4wks/UDCA+metformin for 4wks</arm_group_label>
    <other_name>Ursa tab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metformin</intervention_name>
    <description>Day 29 to 56: Metformin 500mg bid</description>
    <arm_group_label>UDCA for 4wks/UDCA+metformin for 4wks</arm_group_label>
    <other_name>Diabex tab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Day 1 to 56: Placebo bid</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Subjects aged 18 - 50 years&#xD;
&#xD;
          -  A body mass index (BMI) in the range of 25.0 kg/m2 - 30.0 kg/m2.&#xD;
&#xD;
          -  A alanine aminotransferase (ALT) in the range of 40 - 200 IU/L&#xD;
&#xD;
          -  Good health based on complete medical history, physical examinations, vital signs,&#xD;
             electrocardiography (ECG), and clinical laboratory evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have clinically significant disease of cardiovascular, respiratory,&#xD;
             renal, endocrinological, hematological, gastrointestinal, neurological(central nervous&#xD;
             system), psychiatric disorders or malignant tumor&#xD;
&#xD;
          -  Subject judged not eligible for study participation by investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jae-Yong Chung, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>So Hee Jung</last_name>
    <phone>+82-31-787-3968</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Heecahn Lee</last_name>
    <phone>+82-2-2072-4083</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae-Yong Chung, MD, PhD</last_name>
      <phone>+82-031-787-3955</phone>
    </contact>
    <investigator>
      <last_name>Jae-Yong Chung, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>June 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 22, 2016</last_update_submitted>
  <last_update_submitted_qc>December 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jae Yong Chung, MD, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Ursodeoxycholic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03000218
org study id: UDCA_overweight_LFTabnormal
nct id: NCT03000218
lead sponsor: 
has dmc: No
A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are
      overweight and have liver problems after ursodeoxycholic acid multiple administration
This study has a randomized, open-label, three-treatment, one-sequence, placebo-controlled,
      multiple drug administration design. The purpose of this study is as follows; To evaluate
      pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver
      problems after ursodeoxycholic acid administration
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid
time frame: Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h
measure: Change from Baseline Low-density lipoprotein cholesterol at 8 weeks
time frame: Day 1, 29, 57, 71 predose (0h)
arm group label: UDCA 8 wks
arm group type: Experimental
description: Day 1 to 56: Ursodeoxycholic acid 300mg bid
arm group label: UDCA for 4wks/UDCA+metformin for 4wks
arm group type: Experimental
description: Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid
arm group label: Placebo
arm group type: Placebo Comparator
description: Day 1 to 56: Placebo bid
intervention type: Drug
intervention name: Ursodeoxycholic acid
description: Ursodeoxycholic acid 300mg bid for 8 weeks
arm group label: UDCA 8 wks
arm group label: UDCA for 4wks/UDCA+metformin for 4wks
other name: Ursa tab
intervention type: Drug
intervention name: Metformin
description: Day 29 to 56: Metformin 500mg bid
arm group label: UDCA for 4wks/UDCA+metformin for 4wks
other name: Diabex tab
intervention type: Drug
intervention name: Placebo
description: Day 1 to 56: Placebo bid
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jae-Yong Chung, M.D., Ph.D
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: So Hee Jung
phone: +82-31-787-3968
last name: Heecahn Lee
phone: +82-2-2072-4083
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jae Yong Chung, MD, PhD
investigator title: Principal Investigator
mesh term: Overweight
mesh term: Metformin
mesh term: Ursodeoxycholic Acid
sharing ipd: Undecided