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

Healthy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Healthy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Augmentin tablet

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

GSTT1/GSTM1 wild/null typeAugmentin tablet

GSTT1/GSTM1 null/wild typeAugmentin tablet

GSTT1/GSTM1 null/null typeAugmentin tablet

Study Status

Completed

Start Date: December 2013

Completed Date: September 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Aspartate Aminotransferase (AST)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: In-Jin Jang, MD, PhD

Lead Sponsor: Seoul National University Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02143323

Discuss Augmentin