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A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen

Primary Purpose

Fungal Infection

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Voriconazole Oral Product (Vfend®)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fungal Infection

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Those who have been informed of the nature of the trial and have voluntarily agreed to participate in this study and have signed an IRB approved consent before all screening tests
  • Healthy Korean male and female volunteers aged 20 to 45
  • Those with a body weight of 50 kg or more and less than 90 kg and a body mass index (BMI) of 18 or more and less than 27 (BMI(kg/m2) = body weight (kg)/{height(m)}2
  • CYP2C19 EM or PM

Exclusion Criteria:

  • Subjects with clinical evidence of significant respiratory, circulatory, renal, hepatic, endocrine, blood, neuropsychiatric, skeletal or other chronic diseases, alcohol or drug addiction
  • Subjects with a history of gastrointestinal disorders (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test drug
  • Those with a history of substance abuse within the last 2 months
  • Those who have taken any prescribed medicines or herbal medicines within 2 weeks prior to the date of the first medicines, or those taking any general medicines (OTC) or vitamin preparations (eligible if the other conditions are reasonable according to the judgment of the investigator)
  • Those who donate blood within 30 days before the date of the first dose or who have participated in the clinical study of other clinical trial drugs or marketed drugs within 3 months
  • Those who have had significant adverse reactions such as hypersensitivity reactions to azole drugs including drugs for clinical research
  • Those who are not planning on or planning to have a pregnancy during the trial and are not able to use a recognized method of contraception (eg, sterilization surgery of the person and partner, intrauterine contraceptive device, or diaphragm contraception (such as diaphragm or condom use)
  • Persons who are continuously drinking (21 units / week, 1 unit = 10 g of pure alcohol) or who can not abstain from 3 days before the first dose to the end of the clinical trial
  • Those who smoked more than 10 cigarettes per day for the last 3 months or who can not quit smoking 3 days before the first dose
  • Those who consume grapefruit / caffeine-containing food within 3 days of the first dose or who cannot be prohibited during the clinical study period
  • Screening tests for urine pregnancy (β-hCG) positive or lactating women
  • Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • A person who is found to be unsuitable for participation in clinical research due to safety laboratory results or other reasons

Sites / Locations

  • Seoul National University Hospital Clinical Trial Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Voriconazole TBD mg tablet orally, every 12 hours for 7 days

Arm Description

Outcomes

Primary Outcome Measures

Peak plasma concentration (Cmax)
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast)
Pharmacokinetic sampling after administration of drugs from day 1 to day 7

Secondary Outcome Measures

Genetic polymorphisms of CYP2C9 and CYP3A4
Exploratory evaluation
Hepatic safety marker of miRNA-122
Exploratory safety evaluation
Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)
Safety and tolerability evaluation
Physical examination (list of current medications)
Safety and tolerability evaluation
Physical examination (list of any symptoms or pain)
Safety and tolerability evaluation
Physical examination (Medical and surgical history)
Safety and tolerability evaluation
Evaluation of Vital signs (body temperature °C)
Safety and tolerability evaluation
Evaluation of Vital signs (blood pressure mmHg)
Safety and tolerability evaluation
Evaluation of Vital signs (pulse (heart rate, beats per minute))
Safety and tolerability evaluation
Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))
Safety and tolerability evaluation
Safety and tolerability evaluation by 12-lead ECG (P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval, U wave)
Safety and tolerability evaluation
number of participants with abnormal laboratory values (hematologic, chemical, urine)
Safety and tolerability evaluation

Full Information

First Posted
November 23, 2018
Last Updated
November 29, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03760276
Brief Title
A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen
Official Title
A Pilot Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen Based on the Population Pharmacokinetic Model and the Influence of Sex on the Pharmacokinetics of Voriconazole
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
October 28, 2018 (Actual)
Study Completion Date
October 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
A pilot study was performed to evaluate the appropriateness of the voriconazole dosing regimen based on the population pharmacokinetic model and the influence of sex on the pharmacokinetics of voriconazole

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Voriconazole TBD mg tablet orally, every 12 hours for 7 days
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Voriconazole Oral Product (Vfend®)
Intervention Description
To be determined mg of Voriconazole (Vfend®, anti-fungal agent)
Primary Outcome Measure Information:
Title
Peak plasma concentration (Cmax)
Description
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
Time Frame
Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Title
Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast)
Description
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
Time Frame
Day 1 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours, Day 5 12 hours, Day 6 0, 12 hours, Day 7 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours
Secondary Outcome Measure Information:
Title
Genetic polymorphisms of CYP2C9 and CYP3A4
Description
Exploratory evaluation
Time Frame
Day 1 0 hour
Title
Hepatic safety marker of miRNA-122
Description
Exploratory safety evaluation
Time Frame
Day 1 0 hour, Day 5 12 hour, Day 7 12 hour
Title
Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
Physical examination (list of current medications)
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
Physical examination (list of any symptoms or pain)
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
Physical examination (Medical and surgical history)
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
Evaluation of Vital signs (body temperature °C)
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
Evaluation of Vital signs (blood pressure mmHg)
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
Evaluation of Vital signs (pulse (heart rate, beats per minute))
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
Safety and tolerability evaluation by 12-lead ECG (P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval, U wave)
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12
Title
number of participants with abnormal laboratory values (hematologic, chemical, urine)
Description
Safety and tolerability evaluation
Time Frame
Day 1 to Day 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Those who have been informed of the nature of the trial and have voluntarily agreed to participate in this study and have signed an IRB approved consent before all screening tests Healthy Korean male and female volunteers aged 20 to 45 Those with a body weight of 50 kg or more and less than 90 kg and a body mass index (BMI) of 18 or more and less than 27 (BMI(kg/m2) = body weight (kg)/{height(m)}2 CYP2C19 EM or PM Exclusion Criteria: Subjects with clinical evidence of significant respiratory, circulatory, renal, hepatic, endocrine, blood, neuropsychiatric, skeletal or other chronic diseases, alcohol or drug addiction Subjects with a history of gastrointestinal disorders (Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of the test drug Those with a history of substance abuse within the last 2 months Those who have taken any prescribed medicines or herbal medicines within 2 weeks prior to the date of the first medicines, or those taking any general medicines (OTC) or vitamin preparations (eligible if the other conditions are reasonable according to the judgment of the investigator) Those who donate blood within 30 days before the date of the first dose or who have participated in the clinical study of other clinical trial drugs or marketed drugs within 3 months Those who have had significant adverse reactions such as hypersensitivity reactions to azole drugs including drugs for clinical research Those who are not planning on or planning to have a pregnancy during the trial and are not able to use a recognized method of contraception (eg, sterilization surgery of the person and partner, intrauterine contraceptive device, or diaphragm contraception (such as diaphragm or condom use) Persons who are continuously drinking (21 units / week, 1 unit = 10 g of pure alcohol) or who can not abstain from 3 days before the first dose to the end of the clinical trial Those who smoked more than 10 cigarettes per day for the last 3 months or who can not quit smoking 3 days before the first dose Those who consume grapefruit / caffeine-containing food within 3 days of the first dose or who cannot be prohibited during the clinical study period Screening tests for urine pregnancy (β-hCG) positive or lactating women Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. A person who is found to be unsuitable for participation in clinical research due to safety laboratory results or other reasons
Facility Information:
Facility Name
Seoul National University Hospital Clinical Trial Center
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen

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