A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

Not Applicable

Completed

• Conditions: Drug-Induced Liver Injury; Adverse Drug Event; Tuberculosis
• Interventions: Drug: Isoniazid

• Registration Number: NCT03665402
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-13
• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Status Verified: 2018-12
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-31
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid metabolizer (Standard treatment)	Isoniazid	Standard isoniazid dose regimen (300 mg qd)
Slow metabolizer (Standard treatment)	Isoniazid	Standard isoniazid dose regimen (300 mg qd)
Slow metabolizer (PGx treatment)	Isoniazid	Decreased isoniazid dose regimen (200 mg qd)

Primary Outcome Measures

Name	Time	Method
Liver toxicity	up to 4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Drug exposure	Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose	Plasma isoniazid concentration

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trials Center; 🇰🇷 Seoul, Korea, Republic of