A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen

Fungal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03760276
• Other study ID #: Voriconazole_CYP2C19
• Status: Completed
• Phase: Phase 1
• Start date: August 20, 2018
• Est. completion date: October 28, 2018

Study information

• Verified date: November 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 28, 2018
• Est. primary completion date: October 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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 (ß-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

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• Voriconazole Oral Product (Vfend®)
To be determined mg of Voriconazole (Vfend®, anti-fungal agent)

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	Peak plasma concentration (Cmax)	Pharmacokinetic sampling after administration of drugs from day 1 to day 7	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
Primary	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	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	Genetic polymorphisms of CYP2C9 and CYP3A4	Exploratory evaluation	Day 1 0 hour
Secondary	Hepatic safety marker of miRNA-122	Exploratory safety evaluation	Day 1 0 hour, Day 5 12 hour, Day 7 12 hour
Secondary	Safety and tolerability evaluation by monitoring adverse events (number of subjects and cases)	Safety and tolerability evaluation	Day 1 to Day 12
Secondary	Physical examination (list of current medications)	Safety and tolerability evaluation	Day 1 to Day 12
Secondary	Physical examination (list of any symptoms or pain)	Safety and tolerability evaluation	Day 1 to Day 12
Secondary	Physical examination (Medical and surgical history)	Safety and tolerability evaluation	Day 1 to Day 12
Secondary	Evaluation of Vital signs (body temperature °C)	Safety and tolerability evaluation	Day 1 to Day 12
Secondary	Evaluation of Vital signs (blood pressure mmHg)	Safety and tolerability evaluation	Day 1 to Day 12
Secondary	Evaluation of Vital signs (pulse (heart rate, beats per minute))	Safety and tolerability evaluation	Day 1 to Day 12
Secondary	Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))	Safety and tolerability evaluation	Day 1 to Day 12
Secondary	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	Day 1 to Day 12
Secondary	number of participants with abnormal laboratory values (hematologic, chemical, urine)	Safety and tolerability evaluation	Day 1 to Day 12

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