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

NCT ID: NCT02906176

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-01-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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SLCO2B1 wild type

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

Group Type EXPERIMENTAL

Vfend (voriconazole) intravenous infusion

Intervention Type DRUG

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h

Vfend (voriconazole) tablet

Intervention Type DRUG

Vfend (voriconazole) 200 mg tablet once

SLCO2B1 variant

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

Group Type EXPERIMENTAL

Vfend (voriconazole) intravenous infusion

Intervention Type DRUG

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h

Vfend (voriconazole) tablet

Intervention Type DRUG

Vfend (voriconazole) 200 mg tablet once

Interventions

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Vfend (voriconazole) intravenous infusion

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h

Intervention Type DRUG

Vfend (voriconazole) tablet

Vfend (voriconazole) 200 mg tablet once

Intervention Type DRUG

Other Intervention Names

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IV Oral

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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SeungHwan Lee

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SeungHwan Lee, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CYP2C19-SLCO2B1

Identifier Type: -

Identifier Source: org_study_id