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

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.

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Key information

Conditions

Healthy Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Related Side Effects and Adverse Reactions Liver Diseases Poisoning

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jieon Lee, Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
Healthy male of female subjects aged 20 - 45 years
Subjects whose body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (exclusive)

Exclusion criteria

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
Subject who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration
Subject who did blood donation during 1 months before the study or Blood donation during 2 months before the study
Subject with presence or history of severe adverse reaction to study drug
Subject who cannot prevent pregnancy during the study period.
Female subject who are pregnant.
Subject who drank over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization
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.
Subject judged not eligible for study participation by investigator.

Treatment and study plan

Augmentin tablet

Drug

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

Primary outcomes

Aspartate Aminotransferase (AST)

Time frame: 22 days
Alanine Aminotransferase (ALT)

Time frame: 22 days
Alkaline phosphatase (ALP)

Time frame: 22 days

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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)

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: May 21, 2014
Registry last updated: Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed