Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
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ClinicalTrials.gov Identifier: NCT00942773 |
Recruitment Status
:
Completed
First Posted
: July 21, 2009
Last Update Posted
: March 4, 2010
|
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The purpose of this study is to:
- Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Voriconazole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | 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) |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: CYP2C19 extensive metabolizer | Drug: Voriconazole |
Active Comparator: CYP2C19 heterozygous extensive metabolizer | Drug: Voriconazole |
Active Comparator: CYP2C19 poor metabolizer | Drug: Voriconazole |
- Plasma concentration of voriconazole
- Adverse events collected by investigator questionnaire and subjects spontaneous report
- 12-lead ECG
- Clinical laboratory test
- Vital signs

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Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942773
Korea, Republic of | |
Seoul National University Hospital Clinical Trial Center | |
Seoul, Korea, Republic of, 110-744 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | In-Jin Jang, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00942773 History of Changes |
Other Study ID Numbers: |
SNUCPT09_Vori2C19_A |
First Posted: | July 21, 2009 Key Record Dates |
Last Update Posted: | March 4, 2010 |
Last Verified: | March 2010 |
Keywords provided by Seoul National University Hospital:
Healthy volunteer |
Additional relevant MeSH terms:
Voriconazole Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors |