Back to resultsA Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
Primary Purpose
Tuberculosis, Drug-Induced Liver Injury, Adverse Drug Event
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Isoniazid
Sponsored by
About this trial
This is an interventional prevention trial for Tuberculosis
Eligibility Criteria
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
Sites / Locations
- Seoul National University Hospital Clinical Trials Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Rapid metabolizer (Standard treatment)
Slow metabolizer (Standard treatment)
Slow metabolizer (PGx treatment)
Arm Description
Standard isoniazid dose regimen (300 mg qd)
Standard isoniazid dose regimen (300 mg qd)
Decreased isoniazid dose regimen (200 mg qd)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Drug exposure
Plasma isoniazid concentration
Full Information
NCT ID
NCT03665402
First Posted
August 21, 2018
Last Updated
February 26, 2020
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03665402
Brief Title
A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
Official Title
Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 13, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Drug-Induced Liver Injury, Adverse Drug Event
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rapid metabolizer (Standard treatment)
Arm Type
Active Comparator
Arm Description
Standard isoniazid dose regimen (300 mg qd)
Arm Title
Slow metabolizer (Standard treatment)
Arm Type
Active Comparator
Arm Description
Standard isoniazid dose regimen (300 mg qd)
Arm Title
Slow metabolizer (PGx treatment)
Arm Type
Experimental
Arm Description
Decreased isoniazid dose regimen (200 mg qd)
Intervention Type
Drug
Intervention Name(s)
Isoniazid
Intervention Description
One of the first line anti-tubercolosis drug
Primary Outcome Measure Information:
Title
Liver toxicity
Description
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
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Drug exposure
Description
Plasma isoniazid concentration
Time Frame
Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital Clinical Trials Center
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status
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