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OpenTrials
Completed

NCT Number: NCT02906176

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vfend (voriconazole) intravenous infusion

Drug

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h

Other names: IV

Vfend (voriconazole) tablet

Drug

Vfend (voriconazole) 200 mg tablet once

Other names: Oral

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 19, 2016
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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