A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

Seoul National University Hospital16 enrolled

Overview

A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Tuberculosis Drug-Induced Liver Injury Adverse Drug Event

Interventions

IsoniazidDRUG

One of the first line anti-tubercolosis drug

Eligibility

Sex: ALLMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Agreement with written informed consent * Adult healthy male or female subject age 20 to 45 Exclusion Criteria: * Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy * Medication with any drug which may affect the pharmacokinetics of isoniazid within 14 days * Previously donate whole blood within 30 days or Previously participated in other trial within 60 days * Subject with known for hypersensitivity reactions to isoniazid * Subject who can not perform contraception during study periods * Female woman who are pregnant or are breast feeding * An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Locations (1)

Seoul National University Hospital Clinical Trials Center

Seoul, South Korea

Outcomes

Primary Outcomes

Liver toxicity

Number of participants with drug-induced liver injury as assessed by below criteria. * AST or ALT \> 5 ULN * AST or ALT \> 3 ULN and total bilirubin \> 2 ULN (Hy's law case) * ALT ratio/ALP ratio \> 5

Time frame: up to 4 weeks

Secondary Outcomes

Drug exposure

Plasma isoniazid concentration

Time frame: Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose

Data from ClinicalTrials.gov

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