Back to resultsA Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Augmentin tablet
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring GST, DILI, biomarker
Eligibility Criteria
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.
Sites / Locations
- Jieon Lee
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild
GSTT1/GSTM1 wild/null type
GSTT1/GSTM1 null/wild type
GSTT1/GSTM1 null/null type
Arm Description
Augmentin tablet
Augmentin tablet
Augmentin tablet
Augmentin tablet
Outcomes
Primary Outcome Measures
Aspartate Aminotransferase (AST)
Alanine Aminotransferase (ALT)
Alkaline phosphatase (ALP)
Secondary Outcome Measures
Full Information
NCT ID
NCT02143323
First Posted
January 18, 2014
Last Updated
December 22, 2014
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02143323
Brief Title
A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
GST, DILI, biomarker
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild
Arm Type
Active Comparator
Arm Description
Augmentin tablet
Arm Title
GSTT1/GSTM1 wild/null type
Arm Type
Active Comparator
Arm Description
Augmentin tablet
Arm Title
GSTT1/GSTM1 null/wild type
Arm Type
Active Comparator
Arm Description
Augmentin tablet
Arm Title
GSTT1/GSTM1 null/null type
Arm Type
Active Comparator
Arm Description
Augmentin tablet
Intervention Type
Drug
Intervention Name(s)
Augmentin tablet
Other Intervention Name(s)
Experimental: Augmentin, Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days
Primary Outcome Measure Information:
Title
Aspartate Aminotransferase (AST)
Time Frame
22 days
Title
Alanine Aminotransferase (ALT)
Time Frame
22 days
Title
Alkaline phosphatase (ALP)
Time Frame
22 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jin Jang, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jieon Lee
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)
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