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Completed

NCT Number: NCT03760276

A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen

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

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Key information

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital Clinical Trial Center

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voriconazole Oral Product (Vfend®)

Drug

To be determined mg of Voriconazole (Vfend®, anti-fungal agent)

Primary outcomes

  1. Peak plasma concentration (Cmax)

    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

    Pharmacokinetic sampling after administration of drugs from day 1 to day 7

  2. Area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast)

    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

    Pharmacokinetic sampling after administration of drugs from day 1 to day 7

Secondary outcomes

  1. Genetic polymorphisms of CYP2C9 and CYP3A4

    Time frame: Day 1 0 hour

    Exploratory evaluation

  2. Hepatic safety marker of miRNA-122

    Time frame: Day 1 0 hour, Day 5 12 hour, Day 7 12 hour

    Exploratory safety evaluation

  3. Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  4. Physical examination (list of current medications)

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  5. Physical examination (list of any symptoms or pain)

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  6. Physical examination (Medical and surgical history)

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  7. Evaluation of Vital signs (body temperature °C)

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  8. Evaluation of Vital signs (blood pressure mmHg)

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  9. Evaluation of Vital signs (pulse (heart rate, beats per minute))

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  10. Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  11. 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)

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

  12. number of participants with abnormal laboratory values (hematologic, chemical, urine)

    Time frame: Day 1 to Day 12

    Safety and tolerability evaluation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2018
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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