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

This study has been completed.
Sponsor:
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
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
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:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Plasma concentration of voriconazole [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events collected by investigator questionnaire and subjects spontaneous report [ Designated as safety issue: Yes ]
  • 12-lead ECG [ Designated as safety issue: Yes ]
  • Clinical laboratory test [ Designated as safety issue: Yes ]
  • Vital signs [ Designated as safety issue: Yes ]
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
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Seoul National University Hospital

Additional 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
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Healthy volunteer

Additional relevant MeSH terms:
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015