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CompletedNCT02143323Updated Dec 23, 2014

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

A Phase 1 interventional study of Augmentin tablet in Healthy, sponsored by Seoul National University Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-23.

Sponsored by Seoul National University Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
20 Years to 45 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Healthy

Keywords

  • GST, DILI, biomarker
03

In context

Chemical and Drug Induced Liver Injury

75 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 20 are open to participants now.

This study's enrollment of 32 is below the median of 80 across 36 interventional studies indexed under Chemical and Drug Induced Liver Injury.

Browse Chemical and Drug Induced Liver Injury studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild

    Augmentin tablet

    Drug: Augmentin tablet

  • Active comparator
    GSTT1/GSTM1 wild/null type

    Augmentin tablet

    Drug: Augmentin tablet

  • Active comparator
    GSTT1/GSTM1 null/wild type

    Augmentin tablet

    Drug: Augmentin tablet

  • Active comparator
    GSTT1/GSTM1 null/null type

    Augmentin tablet

    Drug: Augmentin tablet

Interventions

  • DrugAugmentin tablet

    Also known as: Experimental: Augmentin, Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days

06

What researchers measure

Primary outcomes

  1. Aspartate Aminotransferase (AST)

    Time frame: 22 days

  2. Alanine Aminotransferase (ALT)

    Time frame: 22 days

  3. Alkaline phosphatase (ALP)

    Time frame: 22 days

07

Study locations

2 sites
  • Jieon Lee
    Seoul, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02143323
Lead sponsor
Seoul National University Hospital
Responsible party
In-Jin Jang, MD, PhD (Professor, Seoul National University Hospital) — Principal investigator
First posted
May 21, 2014
Start date
Dec 2013
Primary completion
Aug 2014
Completion
Sep 2014
Last update
Dec 23, 2014

Study contacts

In-Jin Jang, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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