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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02906176
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
4
Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Vfend (voriconazole) intravenous infusion
  • Drug: Vfend (voriconazole) tablet
 Phase 1

Study Design

Study Type:
Interventional
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 :
Sep 1, 2016
Actual Primary Completion Date :
Nov 1, 2016
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

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 Names:
  • IV

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    2. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Clinical Trial Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: SeungHwan Lee, MD., PhD., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SeungHwan Lee, Assistant Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02906176
    Other Study ID Numbers:
    • CYP2C19-SLCO2B1
    First Posted:
    Sep 19, 2016
    Last Update Posted:
    Oct 25, 2017
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Voriconazole

    Study Results

    No Results Posted as of Oct 25, 2017