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Completed

NCT Number: NCT03665402

A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

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

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Key information

Conditions

Tuberculosis Actinomycetales Infections Adverse Drug Event Bacterial Infections Bacterial Infections and Mycoses Chemical and Drug Induced Liver Injury Chemically-Induced Disorders Digestive System Diseases Drug-Induced Liver Injury Drug-Related Side Effects and Adverse Reactions Gram-Positive Bacterial Infections Infections Liver Diseases Mycobacterium Infections Poisoning

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital Clinical Trials Center

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isoniazid

Drug

One of the first line anti-tubercolosis drug

Primary outcomes

  1. Liver toxicity

    Time frame: 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 outcomes

  1. Drug exposure

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

    Plasma isoniazid concentration

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study title

Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 11, 2018
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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