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

NCT ID: NCT02143323

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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GST, DILI, biomarker

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Augmentin tablet

Group Type ACTIVE_COMPARATOR

Augmentin tablet

Intervention Type DRUG

GSTT1/GSTM1 wild/null type

Augmentin tablet

Group Type ACTIVE_COMPARATOR

Augmentin tablet

Intervention Type DRUG

GSTT1/GSTM1 null/wild type

Augmentin tablet

Group Type ACTIVE_COMPARATOR

Augmentin tablet

Intervention Type DRUG

GSTT1/GSTM1 null/null type

Augmentin tablet

Group Type ACTIVE_COMPARATOR

Augmentin tablet

Intervention Type DRUG

Interventions

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Augmentin tablet

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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In-Jin Jang, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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In-Jin Jang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Jieon Lee

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DILI_Healthy

Identifier Type: -

Identifier Source: org_study_id