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

A Clinical Trail to Investigate the Influence of SLCO2B1 Polymorphism on the Pharmacokinetic Characteristics of Voriconazole in CYP2C19 Poor Metabolizers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02906176

Enrollment

Registered

2016-09-19

Start date

2016-09-30

Completion date

2017-01-31

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DRUGVfend (voriconazole) intravenous infusion

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h

DRUGVfend (voriconazole) tablet

Vfend (voriconazole) 200 mg tablet once

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic outcome - Maximum plasma concentration (Cmax)	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)	predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026