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

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ClinicalTrials.gov Identifier: NCT02143323
Recruitment Status : Completed
First Posted : May 21, 2014
Last Update Posted : December 23, 2014
Sponsor:
Information provided by (Responsible Party):
In-Jin Jang, MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Augmentin tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Active Comparator: Glutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild
Augmentin tablet
Drug: Augmentin tablet
Other Names:
  • Experimental: Augmentin
  • Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days

Active Comparator: GSTT1/GSTM1 wild/null type
Augmentin tablet
Drug: Augmentin tablet
Other Names:
  • Experimental: Augmentin
  • Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days

Active Comparator: GSTT1/GSTM1 null/wild type
Augmentin tablet
Drug: Augmentin tablet
Other Names:
  • Experimental: Augmentin
  • Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days

Active Comparator: GSTT1/GSTM1 null/null type
Augmentin tablet
Drug: Augmentin tablet
Other Names:
  • Experimental: Augmentin
  • Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days




Primary Outcome Measures :
  1. Aspartate Aminotransferase (AST) [ Time Frame: 22 days ]
  2. Alanine Aminotransferase (ALT) [ Time Frame: 22 days ]
  3. Alkaline phosphatase (ALP) [ Time Frame: 22 days ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143323


Locations
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Korea, Republic of
Jieon Lee
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: In-Jin Jang, MD, PhD Seoul National University Hospital

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Responsible Party: In-Jin Jang, MD, PhD, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02143323     History of Changes
Other Study ID Numbers: DILI_Healthy
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by In-Jin Jang, MD, PhD, Seoul National University Hospital:
GST, DILI, biomarker

Additional relevant MeSH terms:
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Chemical and Drug Induced Liver Injury
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action