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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02143323

Enrollment

Registered

2014-05-21

Start date

2013-12-31

Completion date

2014-09-30

Last updated

2014-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

GST, DILI, biomarker

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.

Interventions

DRUGAugmentin tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Aspartate Aminotransferase (AST)	22 days
Alanine Aminotransferase (ALT)	22 days
Alkaline phosphatase (ALP)	22 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026