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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Voriconazole

• Registration Number: NCT00942773
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-20
• Study First Posted: 2009-07-21
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-02
• Last Update Posted: 2010-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYP2C19 extensive metabolizer	Voriconazole	-
CYP2C19 heterozygous extensive metabolizer	Voriconazole	-
CYP2C19 poor metabolizer	Voriconazole	-

Primary Outcome Measures

Name	Time	Method
Plasma concentration of voriconazole

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of