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Report for Clinical Trial NCT02906176

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

NCT02906176 Healthy Volunteers

2 Interventions

Name: Vfend (voriconazole) intravenous infusion

Description: Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h

Type: Drug

SLCO2B1 variant SLCO2B1 wild type

Name: Vfend (voriconazole) tablet

Description: Vfend (voriconazole) 200 mg tablet once

Type: Drug

SLCO2B1 variant SLCO2B1 wild type


Primary Outcomes

Measure: Pharmacokinetic outcome - Maximum plasma concentration (Cmax)

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

Measure: Pharmacokinetic outcome - Area under the plasma concentration versus time curve (AUC)

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

Purpose: Basic Science

Allocation: Non-Randomized

Crossover Assignment


There is one SNP

SNPs


1 rs3781727

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 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 Healthy Volunteers null



HPO Nodes