A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

February 26, 2020 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital Clinical Trials Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rapid metabolizer (Standard treatment)
Standard isoniazid dose regimen (300 mg qd)
Drug: Isoniazid
One of the first line anti-tubercolosis drug
Active Comparator: Slow metabolizer (Standard treatment)
Standard isoniazid dose regimen (300 mg qd)
Drug: Isoniazid
One of the first line anti-tubercolosis drug
Experimental: Slow metabolizer (PGx treatment)
Decreased isoniazid dose regimen (200 mg qd)
Drug: Isoniazid
One of the first line anti-tubercolosis drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Health & Welfare, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INH NAT2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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