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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00942773

Enrollment

Registered

2009-07-21

Start date

2008-12-31

Completion date

2009-03-31

Last updated

2010-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy volunteer

Brief summary

The purpose of this study is to: * Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.

Interventions

DRUGVoriconazole

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Plasma concentration of voriconazole	—

Secondary

Measure	Time frame
Adverse events collected by investigator questionnaire and subjects spontaneous report	—
12-lead ECG	—
Clinical laboratory test	—
Vital signs	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026