Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole

Study Overview
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Brief Summary
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The purpose of this study is to: Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.

Official Title
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Clinical Trials to Evaluate the Influence of CYP2C19 Genotype and Drug-drug Interactions on the Pharmacokinetics of Voriconazole in Healthy Korean Male Volunteers (Part A)

Conditions
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Healthy

Intervention / Treatment
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* Drug: Voriconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects aged 20 - 50 years. A body mass index (BMI) in the range 17-28 kg/m2. Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures. Exclusion Criteria: Presence or history of severe adverse reaction to any drug or a history of severe allergic disease. Clinically relevant abnormal medical history that could interfere with the objectives of the study. Presence or history of eye disease or eye field defect. A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug. A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range. A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg. Presence or history of drug abuse. Participation in other clinical trial within 2 months. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose. Blood donation during 2 months or apheresis during 1 month before the study. Presence or history of alcohol abuse. Smoking of more than 10 cigarettes/day. Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period. Subject judged not eligible for study participation by investigator.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CYP2C19 extensive metabolizer<br> | Drug: Voriconazole<br> <br> |
| Active Comparator: CYP2C19 heterozygous extensive metabolizer<br> | Drug: Voriconazole<br> <br> |
| Active Comparator: CYP2C19 poor metabolizer<br> | Drug: Voriconazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of voriconazole |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collected by investigator questionnaire and subjects spontaneous report |  |  | 
| 12-lead ECG |  |  | 
| Clinical laboratory test |  |  | 
| Vital signs |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer