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NCT02906176 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02906176
Other study ID # CYP2C19-SLCO2B1
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2016
Last updated October 23, 2017
Start date September 2016
Est. completion date January 2017

Study information
Verified date September 2016
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date January 2017
Est. primary completion date November 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Vfend (voriconazole) intravenous infusion
Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h
• Vfend (voriconazole) tablet
Vfend (voriconazole) 200 mg tablet once

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Clinical Trial Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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