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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Augmentin tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT02143323

DILI_Healthy

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

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

Active Comparator group

Description:

Augmentin tablet

Treatment:

Drug: Augmentin tablet

GSTT1/GSTM1 wild/null type

Active Comparator group

Description:

Augmentin tablet

Treatment:

Drug: Augmentin tablet

GSTT1/GSTM1 null/wild type

Active Comparator group

Description:

Augmentin tablet

Treatment:

Drug: Augmentin tablet

GSTT1/GSTM1 null/null type

Active Comparator group

Description:

Augmentin tablet

Treatment:

Drug: Augmentin tablet