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

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143323
• Other study ID #: DILI_Healthy
• Status: Completed
• Phase: Phase 1
• First received: January 18, 2014
• Last updated: December 22, 2014
• Start date: December 2013
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug-Induced Liver Injury
• Healthy

Intervention

Drug:
• Augmentin tablet

Locations

Country	Name	City	State
Korea, Republic of	Jieon Lee	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aspartate Aminotransferase (AST)		22 days	No
Primary	Alanine Aminotransferase (ALT)		22 days	No
Primary	Alkaline phosphatase (ALP)		22 days	No