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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to:

* Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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CYP2C19 extensive metabolizer

Group Type ACTIVE_COMPARATOR

Voriconazole

Intervention Type DRUG

CYP2C19 heterozygous extensive metabolizer

Group Type ACTIVE_COMPARATOR

Voriconazole

Intervention Type DRUG

CYP2C19 poor metabolizer

Group Type ACTIVE_COMPARATOR

Voriconazole

Intervention Type DRUG

Interventions

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Voriconazole

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male subjects aged 20 - 50 years.
2. A body mass index (BMI) in the range 17-28 kg/m2.
3. 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

1. Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
2. Clinically relevant abnormal medical history that could interfere with the objectives of the study.
3. Presence or history of eye disease or eye field defect.
4. 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.
5. A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
6. A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
7. Presence or history of drug abuse.
8. Participation in other clinical trial within 2 months.
9. Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
10. Blood donation during 2 months or apheresis during 1 month before the study.
11. Presence or history of alcohol abuse.
12. Smoking of more than 10 cigarettes/day.
13. Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
14. Subject judged not eligible for study participation by investigator.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes