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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
Sponsor:
Information provided by:
Seoul National University Hospital

Study Description
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Brief Summary:

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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma concentration of voriconazole

Secondary Outcome Measures :
  1. Adverse events collected by investigator questionnaire and subjects spontaneous report
  2. 12-lead ECG
  3. Clinical laboratory test
  4. Vital signs

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

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.
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 contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942773


Locations
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: In-Jin Jang, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00942773    
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:
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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