A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
- Conditions
- Drug-Induced Liver InjuryAdverse Drug EventTuberculosis
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- Agreement with written informed consent
- Adult healthy male or female subject age 20 to 45
- 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
Related Research Topics
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Trial Locations
- Locations (1)
Seoul National University Hospital Clinical Trials Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital Clinical Trials Center🇰🇷Seoul, Korea, Republic of