NCT02906176

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 25, 2017

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

September 12, 2016

Last Update Submit

October 23, 2017

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

SLCO2B1 wild type

EXPERIMENTAL

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 infusionDrug: Vfend (voriconazole) tablet

SLCO2B1 variant

EXPERIMENTAL

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 infusionDrug: Vfend (voriconazole) tablet

Interventions

Vfend (voriconazole) intravenous infusionDRUG

Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h

Also known as: IV
SLCO2B1 variantSLCO2B1 wild type
Vfend (voriconazole) tabletDRUG

Vfend (voriconazole) 200 mg tablet once

Also known as: Oral
SLCO2B1 variantSLCO2B1 wild type

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteer who is a CYP2C19 Poor metabolizer with rs3781727 SNP wild or variant genotype

You may not qualify if:

  • History of clinically significant respiratory, cardiovascular, renal, hepatic, hematologic, neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

Location

MeSH Terms

Interventions

VoriconazoleInfusions, IntravenousTablets

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAdministration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, ParenteralDosage FormsPharmaceutical Preparations

Study Officials

  • SeungHwan Lee, MD., PhD.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 19, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

October 25, 2017

Record last verified: 2016-09

Locations

KR(1)