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

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ClinicalTrials.gov Identifier: NCT02906176
Recruitment Status : Completed
First Posted : September 19, 2016
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
SeungHwan Lee, 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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Vfend (voriconazole) intravenous infusion Drug: Vfend (voriconazole) tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Clinical Trail to Investigate the Influence of SLCO2B1 Polymorphism on the Pharmacokinetic Characteristics of Voriconazole in CYP2C19 Poor Metabolizers
Study Start Date : September 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


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 Name: IV

Drug: Vfend (voriconazole) tablet
Vfend (voriconazole) 200 mg tablet once
Other Name: 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 Name: IV

Drug: Vfend (voriconazole) tablet
Vfend (voriconazole) 200 mg tablet once
Other Name: Oral




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906176


Locations
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Korea, Republic of
Seoul National University Hospital Clinical Trial Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: SeungHwan Lee, MD., PhD. Seoul National University Hospital
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Responsible Party: SeungHwan Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02906176    
Other Study ID Numbers: CYP2C19-SLCO2B1
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors