Influence of SLCO2B1 Polymorphism on the PK of Voriconazole in CYP2C19 PM

Seoul National University Hospital12 enrolled

Overview

A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic characteristics of voriconazole in CYP2C19 poor metabolizers

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Vfend (voriconazole) intravenous infusionDRUG

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h

Vfend (voriconazole) tabletDRUG

Vfend (voriconazole) 200 mg tablet once

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male volunteer who is a CYP2C19 Poor metabolizer with rs3781727 SNP wild or variant genotype Exclusion Criteria: * History of clinically significant respiratory, cardiovascular, renal, hepatic, hematologic, neurological disorder

Locations (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Outcomes

Primary Outcomes

Pharmacokinetic outcome - Maximum plasma concentration (Cmax)

Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose

Pharmacokinetic outcome - Area under the plasma concentration versus time curve (AUC)

Time frame: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose

Data from ClinicalTrials.gov

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