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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 14, 2009
First Posted Date  ICMJE July 21, 2009
Last Update Posted Date March 4, 2010
Study Start Date  ICMJE December 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2009)
Plasma concentration of voriconazole
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
PK parameters of voriconazole; Cmax, AUClast after single IV or oral dosing; Cmax, AUC0-12h after multiple oral dosing; Cmax, AUClast after single administration or rifampicin co-administration
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2009)
  • Adverse events collected by investigator questionnaire and subjects spontaneous report
  • 12-lead ECG
  • Clinical laboratory test
  • Vital signs
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2009)
Safety parameters; adverse events collected by investigator questionnaire and subjects spontaneous report, 12-lead ECG, laboratory test, vital signs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
Official Title  ICMJE 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)
Brief Summary

The purpose of this study is to:

  • Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Voriconazole
Study Arms  ICMJE
  • Active Comparator: CYP2C19 extensive metabolizer
    Intervention: Drug: Voriconazole
  • Active Comparator: CYP2C19 heterozygous extensive metabolizer
    Intervention: Drug: Voriconazole
  • Active Comparator: CYP2C19 poor metabolizer
    Intervention: Drug: Voriconazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2010)
18
Original Actual Enrollment  ICMJE
 (submitted: July 20, 2009)
30
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00942773
Other Study ID Numbers  ICMJE SNUCPT09_Vori2C19_A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party In-Jin Jang, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP