A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen

NCT03760276 | Completed Phase 1

• 1 other identifier: Voriconazole_CYP2C19
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Fungal Infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• Genetic polymorphisms of CYP2C9 and CYP3A4

  Day 1 0 hour

• Hepatic safety marker of miRNA-122

  Day 1 0 hour, Day 5 12 hour, Day 7 12 hour

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

  Day 1 to Day 12

• Physical examination (list of current medications)

  Day 1 to Day 12

• Physical examination (list of any symptoms or pain)

  Day 1 to Day 12

Study Arms (1)

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

EXPERIMENTAL

Drug: Voriconazole Oral Product (Vfend®)

Interventions

Voriconazole Oral Product (Vfend®) DRUG

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

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

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Mycoses

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 23, 2018
• First Posted: November 30, 2018
• Study Start: August 20, 2018
• Primary Completion: October 28, 2018
• Study Completion: October 28, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)