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

Tracking Information
First Received Date ^ICMJE	July 14, 2009
Last Updated Date	March 2, 2010
Start Date ^ICMJE	December 2008
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 [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00942773 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 2, 2009)	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 ]
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 [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Healthy
Intervention ^ICMJE	Drug: Voriconazole
Study Arm (s)	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 *	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. Epub 2012 Apr 13. PubMed PMID: 22503212.
* 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
Enrollment ^ICMJE	18
Completion Date	March 2009
Primary Completion Date	March 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	20 Years to 50 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT00942773
Other Study ID Numbers ^ICMJE	SNUCPT09_Vori2C19_A
Has Data Monitoring Committee	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
Information Provided By	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

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