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NCT03665402 Clinical Trial

A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03665402
Other study ID # INH NAT2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2018
Est. completion date March 31, 2019

Study information
Verified date December 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date March 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Isoniazid
One of the first line anti-tubercolosis drug

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Clinical Trials Center Seoul

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Hospital Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Drug exposure Plasma isoniazid concentration Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose
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