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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Vfend (voriconazole) intravenous infusion; Drug: Vfend (voriconazole) tablet

• Registration Number: NCT02906176
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-19
• Primary Completion: 2016-11
• Study Completion: 2017-01
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SLCO2B1 wild type	Vfend (voriconazole) intravenous infusion	Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)
SLCO2B1 variant	Vfend (voriconazole) intravenous infusion	Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)
SLCO2B1 wild type	Vfend (voriconazole) tablet	Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)
SLCO2B1 variant	Vfend (voriconazole) tablet	Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h (Day 1) - washout period - Vfend (voriconazole) 200 mg tablet once (Day 8)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital Clinical Trial Center; 🇰🇷 Seoul, Korea, Republic of