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Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
This study has been completed.
Sponsor:
Seoul National University Hospital
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00942773
First received: July 14, 2009
Last updated: March 2, 2010
Last verified: March 2010
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Purpose
The purpose of this study is to:
- Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
| Condition | Intervention | Phase |
|---|---|---|
| Healthy | Drug: Voriconazole | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: 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) |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Primary Outcome Measures:
- Plasma concentration of voriconazole
Secondary Outcome Measures:
- Adverse events collected by investigator questionnaire and subjects spontaneous report
- 12-lead ECG
- Clinical laboratory test
- Vital signs
| Enrollment: | 18 |
| Study Start Date: | December 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: CYP2C19 extensive metabolizer | Drug: Voriconazole |
| Active Comparator: CYP2C19 heterozygous extensive metabolizer | Drug: Voriconazole |
| Active Comparator: CYP2C19 poor metabolizer | Drug: Voriconazole |
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00942773
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942773
Locations
| Korea, Republic of | |
| Seoul National University Hospital Clinical Trial Center | |
| Seoul, Korea, Republic of, 110-744 | |
Sponsors and Collaborators
Seoul National University Hospital
More Information
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 |
| Study First Received: | July 14, 2009 |
| Last Updated: | March 2, 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 |
ClinicalTrials.gov processed this record on June 23, 2017