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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Augmentin tablet

• Registration Number: NCT02143323
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-18
• Study First Submitted QC: 2014-05-18
• Study First Posted: 2014-05-21
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild	Augmentin tablet	Augmentin tablet
GSTT1/GSTM1 wild/null type	Augmentin tablet	Augmentin tablet
GSTT1/GSTM1 null/null type	Augmentin tablet	Augmentin tablet
GSTT1/GSTM1 null/wild type	Augmentin tablet	Augmentin tablet

Primary Outcome Measures

Name	Time	Method
Alanine Aminotransferase (ALT)	22 days
Alkaline phosphatase (ALP)	22 days
Aspartate Aminotransferase (AST)	22 days

Trial Locations

Locations (2)

Jieon Lee; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of