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

October 23, 2017 updated by: SeungHwan Lee, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital Clinical Trial Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: Vfend (voriconazole) intravenous infusion
Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h
Other Names:
  • IV
Drug: Vfend (voriconazole) tablet
Vfend (voriconazole) 200 mg tablet once
Other Names:
  • Oral
Experimental: SLCO2B1 variant
Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)
Drug: Vfend (voriconazole) intravenous infusion
Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h
Other Names:
  • IV
Drug: Vfend (voriconazole) tablet
Vfend (voriconazole) 200 mg tablet once
Other Names:
  • Oral

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: SeungHwan Lee, MD., PhD., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CYP2C19-SLCO2B1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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