A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

Seoul National University

Status: Completed

Conditions: Adverse Drug Event; Tuberculosis; Drug-Induced Liver Injury

Treatments: Drug: Isoniazid

Study type: Interventional

Funder types: Other

Identifiers

NCT03665402

INH NAT2

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Rapid metabolizer (Standard treatment)

Active Comparator group

Description:

Standard isoniazid dose regimen (300 mg qd)

Treatment:

Drug: Isoniazid

Slow metabolizer (Standard treatment)

Active Comparator group

Description:

Standard isoniazid dose regimen (300 mg qd)

Treatment:

Drug: Isoniazid

Slow metabolizer (PGx treatment)

Experimental group

Description:

Decreased isoniazid dose regimen (200 mg qd)

Treatment:

Drug: Isoniazid