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

Seoul National University

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Vfend (voriconazole) intravenous infusion; Drug: Vfend (voriconazole) tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT02906176

CYP2C19-SLCO2B1

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

SLCO2B1 wild type

Experimental group

Description:

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)

Treatment:

Drug: Vfend (voriconazole) tablet

Drug: Vfend (voriconazole) intravenous infusion

SLCO2B1 variant

Experimental group

Description:

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)

Treatment:

Drug: Vfend (voriconazole) tablet

Drug: Vfend (voriconazole) intravenous infusion