A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

NCT03665402 | Completed

• 1 other identifier: INH NAT2
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tuberculosis; Drug-Induced Liver Injury; Adverse Drug Event

Outcome Measures

Primary Outcomes (1)

• 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

  up to 4 weeks

Secondary Outcomes (1)

• Drug exposure

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

Study Arms (3)

Rapid metabolizer (Standard treatment)

ACTIVE COMPARATOR

Standard isoniazid dose regimen (300 mg qd)

Drug: Isoniazid

Slow metabolizer (Standard treatment)

ACTIVE COMPARATOR

Standard isoniazid dose regimen (300 mg qd)

Drug: Isoniazid

Slow metabolizer (PGx treatment)

EXPERIMENTAL

Decreased isoniazid dose regimen (200 mg qd)

Drug: Isoniazid

Interventions

Isoniazid DRUG

One of the first line anti-tubercolosis drug

Rapid metabolizer (Standard treatment); Slow metabolizer (PGx treatment); Slow metabolizer (Standard treatment)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Agreement with written informed consent
• Adult healthy male or female subject age 20 to 45

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Health & Welfare, Korea: collaborator

Study Sites (1)

Seoul National University Hospital Clinical Trials Center

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Tuberculosis; Chemical and Drug Induced Liver Injury; Drug-Related Side Effects and Adverse Reactions

Interventions

Isoniazid

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Liver Diseases; Digestive System Diseases; Chemically-Induced Disorders; Poisoning

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 11, 2018
• Study Start: May 13, 2018
• Primary Completion: December 31, 2018
• Study Completion: March 31, 2019
• Last Updated: February 28, 2020

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)