Fungal InfectionPhase 1NCT03760276
A Study to Evaluate the Appropriateness of the Voriconazole Dosing Regimen
A Phase 1 study testing Voriconazole Oral Product (Vfend®) in people with Fungal Infection, run by Seoul National University Hospital at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fungal Infection
- What is being tested?
- Voriconazole Oral Product (Vfend®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Aug 2018to 28 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul, 03080
About this study
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
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
- Being tested
- Voriconazole Oral Product (Vfend®)
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voriconazole Oral Product (Vfend®)Drug
To be determined mg of Voriconazole (Vfend®, anti-fungal agent)
| Study group | Role | What they receive |
|---|---|---|
| Voriconazole TBD mg tablet orally, every 12 hours for 7 days | Experimental | Not described Receives: Drug: Voriconazole Oral Product (Vfend®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax)
Pharmacokinetic sampling after administration of drugs from day 1 to day 7
Measured: 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
Measured: 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
Exploratory evaluation
Measured: Day 1 0 hour
Hepatic safety marker of miRNA-122
Exploratory safety evaluation
Measured: 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)
Safety and tolerability evaluation
Measured: Day 1 to Day 12
Physical examination (list of current medications)
Safety and tolerability evaluation
Measured: Day 1 to Day 12
Physical examination (list of any symptoms or pain)
Safety and tolerability evaluation
Measured: Day 1 to Day 12
Physical examination (Medical and surgical history)
Safety and tolerability evaluation
Measured: Day 1 to Day 12
Evaluation of Vital signs (body temperature °C)
Safety and tolerability evaluation
Measured: Day 1 to Day 12
Evaluation of Vital signs (blood pressure mmHg)
Safety and tolerability evaluation
Measured: Day 1 to Day 12
Evaluation of Vital signs (pulse (heart rate, beats per minute))
Safety and tolerability evaluation
Measured: Day 1 to Day 12
Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))
Safety and tolerability evaluation
Measured: Day 1 to Day 12
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
Measured: Day 1 to Day 12
number of participants with abnormal laboratory values (hematologic, chemical, urine)
Safety and tolerability evaluation
Measured: Day 1 to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start20 Aug 2018
- Primary completion28 Oct 2018
- Study completion28 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeungHwan Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760276
- Sponsor's protocol ID
- Voriconazole_CYP2C19
- Status last verified
- Nov 2018
- First submitted
- 23 Nov 2018
- Last updated
- 30 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03760276
- Acronym / sponsor ID
- Voriconazole_CYP2C19
- Conditions
- Fungal Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 28 Oct 2018 (actual)
- Study completion
- 28 Oct 2018 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Voriconazole TBD mg tablet orally, every 12 hours for 7 days | Experimental | Drug: Voriconazole Oral Product (Vfend®) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voriconazole Oral Product (Vfend®)To be determined mg of Voriconazole (Vfend®, anti-fungal agent) | Drug | Voriconazole TBD mg tablet orally, every 12 hours for 7 days |
Primary outcome
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
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
12 secondary outcomes
Genetic polymorphisms of CYP2C9 and CYP3A4
Time frame: Day 1 0 hour
Hepatic safety marker of miRNA-122
Time frame: 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)
Time frame: Day 1 to Day 12
Physical examination (list of current medications)
Time frame: Day 1 to Day 12
Physical examination (list of any symptoms or pain)
Time frame: Day 1 to Day 12
Physical examination (Medical and surgical history)
Time frame: Day 1 to Day 12
Evaluation of Vital signs (body temperature °C)
Time frame: Day 1 to Day 12
Evaluation of Vital signs (blood pressure mmHg)
Time frame: Day 1 to Day 12
Evaluation of Vital signs (pulse (heart rate, beats per minute))
Time frame: Day 1 to Day 12
Evaluation of Vital signs (breathing rate (respiratory rate, beats per minute))
Time frame: Day 1 to Day 12
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
number of participants with abnormal laboratory values (hematologic, chemical, urine)
Time frame: Day 1 to Day 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Voriconazole Oral Product (Vfend®) in people with Fungal Infection, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2018.