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A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02143323
Collaborator
(none)
32
Enrollment
2
Locations
4
Arms
9
Duration (Months)
16
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

  • To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate.

  • To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.

Condition or Disease Intervention/Treatment Phase
  • Drug: Augmentin tablet
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Clinical Study to Evaluate the Effect of Glutathion S-transferase Polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Amoxicillin/Clavulanate and Explore Biomarkers for Drug-induced Liver Injury (DILI)
Study Start Date :
Dec 1, 2013
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Sep 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild

Augmentin tablet

Drug: Augmentin tablet
Other Names:
  • Experimental: Augmentin
  • Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days

    		•
    Active Comparator: GSTT1/GSTM1 wild/null type

    Augmentin tablet

    Drug: Augmentin tablet
    Other Names:
  • Experimental: Augmentin
  • Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days

    		•
    Active Comparator: GSTT1/GSTM1 null/wild type

    Augmentin tablet

    Drug: Augmentin tablet
    Other Names:
  • Experimental: Augmentin
  • Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days

    		•
    Active Comparator: GSTT1/GSTM1 null/null type

    Augmentin tablet

    Drug: Augmentin tablet
    Other Names:
  • Experimental: Augmentin
  • Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Aspartate Aminotransferase (AST) [22 days]

    2. Alanine Aminotransferase (ALT) [22 days]

    3. Alkaline phosphatase (ALP) [22 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Subject with sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures

    2. Healthy male of female subjects aged 20 - 45 years

    3. Subjects whose body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (exclusive)

    Exclusion Criteria:

    1. Subject with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history

    2. Subject who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration

    3. Subject who did blood donation during 1 months before the study or Blood donation during 2 months before the study

    4. Subject with presence or history of severe adverse reaction to study drug

    5. Subject who cannot prevent pregnancy during the study period.

    6. Female subject who are pregnant.

    7. Subject who drank over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization

    8. Subject who are Heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization.

    9. Subject judged not eligible for study participation by investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jieon Lee Seoul Korea, Republic of
    2 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: In-Jin Jang, MD, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    In-Jin Jang, MD, PhD, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02143323
    Other Study ID Numbers:
    • DILI_Healthy
    First Posted:
    May 21, 2014
    Last Update Posted:
    Dec 23, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by In-Jin Jang, MD, PhD, Professor, Seoul National University Hospital
    GST, DILI, biomarker
    Additional relevant MeSH terms:
    Chemical and Drug Induced Liver Injury
    Amoxicillin-Potassium Clavulanate Combination

    Study Results

    No Results Posted as of Dec 23, 2014