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

July 14, 2009
March 2, 2010
December 2008
March 2009   (final data collection date for primary outcome measure)
Plasma concentration of voriconazole [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00942773 on ClinicalTrials.gov Archive Site
  • 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 ]
Safety parameters; adverse events collected by investigator questionnaire and subjects spontaneous report, 12-lead ECG, laboratory test, vital signs [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
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)

The purpose of this study is to:

  • Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Healthy
Drug: Voriconazole
  • 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
Lee S, Gu N, Kim BH, Lim KS, Shin SG, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic properties of the calcimimetic agent cinacalcet (KRN1493) in healthy male Korean subjects: a randomized, open-label, single ascending-dose, parallel-group study. Clin Ther. 2012 May;34(5):1160-9. doi: 10.1016/j.clinthera.2012.03.058. Epub 2012 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
March 2009
March 2009   (final data collection date for primary outcome measure)

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.
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00942773
SNUCPT09_Vori2C19_A
Not Provided
In-Jin Jang, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
March 2010

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