NCT02143323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

8 months

First QC Date

January 18, 2014

Last Update Submit

December 22, 2014

Conditions

Healthy

Keywords

GST, DILI, biomarker

Outcome Measures

Primary Outcomes (3)

  • Aspartate Aminotransferase (AST)

    22 days

  • Alanine Aminotransferase (ALT)

    22 days

  • Alkaline phosphatase (ALP)

    22 days

Study Arms (4)

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

ACTIVE COMPARATOR

Augmentin tablet

Drug: Augmentin tablet

GSTT1/GSTM1 wild/null type

ACTIVE COMPARATOR

Augmentin tablet

Drug: Augmentin tablet

GSTT1/GSTM1 null/wild type

ACTIVE COMPARATOR

Augmentin tablet

Drug: Augmentin tablet

GSTT1/GSTM1 null/null type

ACTIVE COMPARATOR

Augmentin tablet

Drug: Augmentin tablet

Interventions

Augmentin tabletDRUG
Also known as: Experimental: Augmentin, Augmentin 3 tablets (Amoxicilin:clavualanate=2:1) bid, for 14days
GSTT1/GSTM1 null/null typeGSTT1/GSTM1 null/wild typeGSTT1/GSTM1 wild/null typeGlutathione S-Transferase Theta1(GSTT1)/Mu1(GSTM1) wild/wild

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jieon Lee

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Interventions

Amoxicillin-Potassium Clavulanate CombinationBID protein, humanWW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersPoisoning

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsShort Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • In-Jin Jang, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2014

First Posted

May 21, 2014

Study Start

December 1, 2013

Primary Completion

August 1, 2014

Study Completion

September 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

KR(2)