Aspergillus InfectionsPhase 1NCT02631954

Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers

A Phase 1 study testing Vorico Injection 200mg(Voriconazole) and Vfend®(Voriconazole) IV 200mg in people with Aspergillus Infections and Candida Infections, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Aspergillus Infections, Candida Infections, Fungal Infections
What is being tested?: Vorico Injection 200mg(Voriconazole) and Vfend®(Voriconazole) IV 200mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteSouth Korea
Study dates: Sep 2015to Nov 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A healthy person whose age is in between 19 to 55 during the screening tests
Whose weight is more than 55 kg, BMI is over 18.5 and under 30.0 during the screening test. (BMI (kg/m2) = weight (kg) / {height (m)}2)
Who is completely informed and understand about this clinical trial, voluntarily participating it, and signed to follow the given instructions
Who is proven to fit into the clinical trial following by physical examination, ECG (electrocardiogram), clinical laboratory test, medical examination
Who agreed to do birth control during testing
A male who did not have vasectomy has to follow the clinically proven contraceptive methods* listed under, and who agreed not to donate sperm during the test

Show all 9Show fewer

Clinically proven contraceptive method: intrauterine device (ex. Lippes Loop, Minera), chemical contraceptive (spermicides) for use with physical contraceptive method (males or females), contraceptive implants (ex. Implanon), tubal ligation or laparoscopy (common methods of tubal ligation)
A woman of childbearing age who agreed on constant use of a medically disproven Dual Protection method** and spermicides except hormonal contraceptive, and who also agreed not to breastfeed.
A Dual Protection method: use of condoms, the Intrauterine Contraceptive Device, the diaphragm, the cervical cap, in the case where a sexual partner had vasectomy over 3 months ago (from the date of initial screening) or a sexual partner had been medically diagnosed sterile.

Who cannot join

A person who has a history of clinically significant cardiovascular, respiratory, liver, kidney, endocrine system, immune system, urinary system diseases, blood-tumor diseases, mental illness.
Who has a history of hypersensitivity reactions to antifungal drugs including voriconazole or similar series or other excipient ingredients (aspirin, antibiotics, etc.)
Who has genetics issues on galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
Who has a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (other than simple appendectomy and herniotomy)
A person whose electrocardiogram value includes QTc > 440 msec, PR < 110 msec or PR > 200 msec, QRS < 60 msec or QRS > 110 msec after screening, or who show clinically significant opinion.
Who falls under the following results

Show all 19Show fewer

AST, ALT are exceeded over 1.5x the upper limit of the normal range
Total bilirubin is exceeded over 1.5x the upper limit of the normal range
Who shows the vital sign values of more than 140 mmHg or less than 90 mmHg in systolic pressure or more than 100 mmHg or less than 60 mmHg in diastolic blood pressure
Who has history of drug abuses or shows a positive result in the urinary drug screen
Who took any prescribed drugs, medicinal plants within the 2 weeks before the first day of dosing or takes any over-the-counter drugs or vitamin supplements within 1 week (but, if other conditions are met, they can still participate in the clinical test through the researcher's judgment)
Who took other investigational drugs or bioequivalence drugs within 3 months before the first day of dosing
Who participated in whole blood donation within 2 months before the first of dosing, or platelet donations within 1 months. Who received blood a month before the first day of dosing
Who constantly drinks alcohol (over 21 units/week, 1 unit = 10 g of pure alcohol) or cannot stop drinking alcohol during the clinical test.
Who smokes more than 10 cigarettes per day, or who cannot quit smoking when hospitalized
Who absorb caffeinated drinks (coffee, tea (black or green tea), soda, coffee flavored milk, energy drinks, etc.) or cannot stop absorbing them 24 hours before hospitalization until discharging
Who takes drug metabolism drug like barbital drugs which inhibit or activate the metabolism or drugs, or who takes one of the following drugs: St. John's Wort, rifabutin, rifampicin, carbamazepine, phenobarbital, high-dose of ritonavir, terfenadine, astemizole, cisapride, pimozide, quinidine, sirolimus, ergot, alkaloid (ergotamine, dihydroergotamine), efavirenz
Who was having foods (especially grapefruit or products contain grapefruit) that can influence the drug absorption, distribution, metabolism, and excretion within 7 days from the first day of dosage
A woman who is pregnant, shows positive result in serum/urine test, or who is breastfeeding

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Inha University Hospital
Incheon, 22332

Other trials in South Korea

About this study

Read the detailed description

To healthy volunteers subjects of twenty four(24), following treatments are administered dosing in each period injected wash-out period is a minimum of 7days. Treatment A(Test Drug): Vorico Injection 200mg(Voriconazole) for Single Dose Treatment B(Reference Drug): Vfend® IV 200mg for Single Dose Pharmacokinetic blood samples are collected up to 24hrs.

Safety and pharmacokinetic are assessed.

Conditions: Aspergillus Infections, Candida Infections, Fungal Infections
Being tested: Vorico Injection 200mg(Voriconazole), Vfend®(Voriconazole) IV 200mg
Medical subject headings: Aspergillosis, Candidiasis, Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vorico Injection 200mg(Voriconazole)Drug
Vorico Injection 200mg(Voriconazole) to administered intravenously once
Vfend®(Voriconazole) IV 200mgDrug
Vfend®(Voriconazole) IV 200mg to administered intravenously once

Study groups in NCT02631954
Study group	Role	What they receive
TR Group	Experimental	Test drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg Receives: Drug: Vorico Injection 200mg(Voriconazole); Drug: Vfend®(Voriconazole) IV 200mg
RT group	Experimental	Reference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole) Receives: Drug: Vorico Injection 200mg(Voriconazole); Drug: Vfend®(Voriconazole) IV 200mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax of Voriconazole
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Measured: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
AUCt of Voriconazole
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Measured: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

Secondary outcomes (5)

Tmax of Voriconazole
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Measured: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
AUCinf of Voriconazole
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Measured: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
AUCt/AUCinf
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Measured: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
Kel (Elemination Rate Constant)
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Measured: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
t1/2
The blood sampleing coleected from the subjects was analyzed and result was obtained.
Measured: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Nov 2015

First posted16 Dec 2015 (estimated)
Study startSep 2015
Primary completionOct 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Aspergillus InfectionsStudies of the same condition, open and under way.
More trials run by Chong Kun Dang PharmaceuticalThe 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02631954
Sponsor's protocol ID: 151HPS14014
Status last verified: Jan 2016
First submitted: 13 Dec 2015
Last updated: 18 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cho SH, Kim CW, Nam MS. Pharmacokinetics and Safety of Two Voriconazole Formulations after Intravenous Infusion in Healthy Korean Volunteers. Infect Chemother. 2020 Jun;52(2):204-211. doi: 10.3947/ic.2020.52.2.204. Epub 2020 May 29.
PubMed 32468741

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
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Invasive Mold Infections
RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Bronchiectasis, Bronchiectasis Adult
Not yet recruitingPhase 3
A Study of Itraconazole and Posaconazole for Chronic Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis
Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
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All Aspergillus Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial for Comparison of Pharmacokinetic Characteristics of Vorico Injection 200mg(Voriconazole) and Vfend® IV 200mg for Single Dose Crossover Intravenous Infusion in Healthy Volunteers
ClinicalTrials.gov ID: NCT02631954
Acronym / sponsor ID: 151HPS14014
Conditions: Aspergillus Infections, Candida Infections, Fungal Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Oct 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 16 Dec 2015 (estimated)
Results: Posted 18 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Safety and pharmacokinetic are assessed.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TR Group	Experimental	Drug: Vorico Injection 200mg(Voriconazole), Drug: Vfend®(Voriconazole) IV 200mgTest drug: Vorico Injection 200mg(Voriconazole) Wash out: 7 days Reference drug: Vfend® IV 200mg
RT group	Experimental	Drug: Vorico Injection 200mg(Voriconazole), Drug: Vfend®(Voriconazole) IV 200mgReference drug: Vfend® IV 200mg Wash out: 7 days Test drug: Vorico Injection 200mg(Voriconazole)

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

A healthy person whose age is in between 19 to 55 during the screening tests
Whose weight is more than 55 kg, BMI is over 18.5 and under 30.0 during the screening test. (BMI (kg/m2) = weight (kg) / {height (m)}2)
Who is completely informed and understand about this clinical trial, voluntarily participating it, and signed to follow the given instructions
Who is proven to fit into the clinical trial following by physical examination, ECG (electrocardiogram), clinical laboratory test, medical examination
Who agreed to do birth control during testing

Key exclusion criteria (19 listed)

A person who has a history of clinically significant cardiovascular, respiratory, liver, kidney, endocrine system, immune system, urinary system diseases, blood-tumor diseases, mental illness.
Who has a history of hypersensitivity reactions to antifungal drugs including voriconazole or similar series or other excipient ingredients (aspirin, antibiotics, etc.)
Who has genetics issues on galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption
Who has a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (other than simple appendectomy and herniotomy)
A person whose electrocardiogram value includes QTc > 440 msec, PR < 110 msec or PR > 200 msec, QRS < 60 msec or QRS > 110 msec after screening, or who show clinically significant opinion.

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
Vorico Injection 200mg(Voriconazole)Vorico Injection 200mg(Voriconazole) to administered intravenously once	Drug	RT group, TR Group
Vfend®(Voriconazole) IV 200mgVfend®(Voriconazole) IV 200mg to administered intravenously once	Drug	RT group, TR Group

Primary outcome

Cmax of Voriconazole
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
The blood sampleing coleected from the subjects was analyzed and result was obtained.
AUCt of Voriconazole
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
The blood sampleing coleected from the subjects was analyzed and result was obtained.

5 secondary outcomes

Tmax of Voriconazole
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
AUCinf of Voriconazole
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
AUCt/AUCinf
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
Kel (Elemination Rate Constant)
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs
t1/2
Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs

Results and safety

Results posted to the registry on 18 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TR Group	12	12
RT Group	12	12

Primary outcome: Cmax of Voriconazole

Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs. Mean (Standard Deviation). Unit: ng/mL

Measure	Reference n = 23	Test n = 23
Value	2433.7 (2456.9)	1997.0 (406.2)

Primary outcome: AUCt of Voriconazole

Time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	Reference n = 23	Test n = 23
Value	6966.17 (2856.10)	7469.78 (3125.73)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reference	0 of 23 (0%)	21 of 23 (91.3%)	0 of 23
Test	0 of 24 (0%)	22 of 24 (91.7%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32468741Cho SH, Kim CW, Nam MS. Pharmacokinetics and Safety of Two Voriconazole Formulations after Intravenous Infusion in Healthy Korean Volunteers. Infect Chemother. 2020 Jun;52(2):204-211. doi: 10.3947/ic.2020.52.2.204. Epub 2020 May 29.

Related trials for Aspergillus Infections

RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.
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RecruitingPhase 3
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
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Not yet recruiting
Real-World Effectiveness of Depemokimab in Allergic Bronchopulmonary Aspergillosis With Severe Eosinophilic Asthma
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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?

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 9 inclusion and 19 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 18 Mar 2020. 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?

Yes. Results are posted in the registry (first posted 18 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax of Voriconazole (time frame: 0 , 0.5, 1, 1.25, 1.5, 1.58, 1.67, 1.83, 2, 2.5, 3, 4, 6, 8, 12, 24 hrs). 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?

On the ClinicalTrials.gov record for NCT02631954, which also lists 1 linked publication.

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 18 Mar 2020.