Superficial MycosesPhase 1NCT02493738
A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers
A Phase 1 study testing Lozanoc 50mg and Sporanox 100mg in people with Superficial Mycoses and Dermatomycoses, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
Study Objectives: To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and fed condition in healthy male subjects To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under fed condition in healthy male subjects To evaluate the safety and tolerability of single… Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Superficial Mycoses, Dermatomycoses, Candidiasis
- What is being tested?
- Lozanoc 50mg and Sporanox 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Oct 2015
- 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Korean male volunteers in the age between 19 and 50 years old (inclusive)
- Subject who are able to give signed informed consent
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighting at least 50kg
- Subject who are considered
- Pre-study physical examination with no clinically significant abnormalities
- No clinically significant medical history
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- Vital signs were to be within reference ranges, or if outside of the range, not deemed clinically significant in the opinion of the Investigator
- 90 mmHg ≤ systolic blood pressure (sitting position) ≤ 140mmHg
- 50 mmHg ≤ diastolic blood pressure (sitting position) ≤ 90 mmHg
- Pre-study clinical laboratory findings were to be within reference range, or if outside of the range, not deemed clinically significant in the opinion of the Investigator
- No clinically significant abnormalities in 12-lead ECG results
- Agree to continue to use at least two accepted methods of birth control and not to donate sperm for at least 1 days before the first dosing, during the course of the study and for a period of 90days following the last dosing.
- Acceptable methods of birth control are: female (sexual partner) hormonal contraceptives; intrauterine device; surgical sterility at least 6 months prior to screening (Ex. hysterectomy, bilateral oophorectomy, and/or tubal ligation); use diaphragm; use condom; or spermicide
Who cannot join
- Subjects will be excluded if they meet any of the following criteria:
- History of allergy or sensitivity to any drug, including any prior serious adverse reaction to antifungal agent(s)
- History of congestive heart failure or Patients with ventricular dysfunction such as congestive heart failure
- Undergone surgery or who have a medical condition, that in the judgment of the Investigator, may affect absorption, distribution, metabolism or elimination of the drug product
- Participated in a previous clinical trial within 90 days prior to screening visit
- Donated blood or had a significant loss of blood within 60 days prior to screening visit
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- Special diet or substantial changes in eating habits within 30 days prior to screening visit
- Use of any prescription medication within 14 days before screening visit
- Use of any other OTC medication within the 7 days before screening visit
- History of smoking within 3 months prior to screening visit
- Have a recent history (within 2 years prior to the screening visit) of alcohol or drug abuse or a positive screen for drugs of abuse at screening
- Positive blood screen for HIV or hepatitis B or C or syphilis
- Clinically important abnormal hepatic function test (AST, ALT greater than 2 fold of reference upper limit (ULN), or total bilirubin greater than 1.5 x ULN)
- Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Single-Center, Randomized, Open-label, Single Dose, Crossover Study in Korean Healthy Male Volunteers to Evaluate Pharmacokinetics of Lozanoc and Sporanox
Study Objectives:
- To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and fed condition in healthy male subjects
- To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under fed condition in healthy male subjects
- To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in Korean healthy male subjects
Read the detailed description
Phase I Study divided into 3 parts written as bellows.
Part I. Lozanoc 50mg single dose under fed condition vs Part 2. Lozanoc 50mg single dose under fasted condition vs Part 3. Sporanox 100mg single dose under fed condition
- Conditions
- Superficial Mycoses, Dermatomycoses, Candidiasis, Histoplasmosis
- Being tested
- Lozanoc 50mg, Sporanox 100mg
- Medical subject headings
- Dermatomycoses, Candidiasis, Histoplasmosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lozanoc 50mgDrug
Lozanoc 50mg single dose under fed and fasted condition
Sporanox 100mgDrug
Sporanox 100mg single dose under fed condition
| Study group | Role | What they receive |
|---|---|---|
| Lozanoc 50mg | Experimental | Lozanoc 50mg, oral administration Receives: Drug: Lozanoc 50mg |
| Sporanox 100mg | Active comparator | Sporanox 100mg, oral administration Receives: Drug: Sporanox 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: 0~120 hour after medication
Secondary outcomes (2)
tmax
Measured: 0~120 hour after medication
AUCinf
Measured: 0~120 hour after medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superficial MycosesStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, M.D., Ph.D., Principal investigator, Department of Clinical Pharmacology and Therapeutics, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493738
- Sponsor's protocol ID
- BR-ITR-CT-101
- Status last verified
- Mar 2016
- First submitted
- 7 Jul 2015
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single-Center, Randomized, Open-label, Single Dose, Crossover Study in Korean Healthy Male Volunteers to Evaluate Pharmacokinetics of Lozanoc and Sporanox
- ClinicalTrials.gov ID
- NCT02493738
- Acronym / sponsor ID
- BR-ITR-CT-101
- Conditions
- Superficial Mycoses, Dermatomycoses, Candidiasis, Histoplasmosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Jul 2015 (estimated)
- 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.
Study Objectives:
- To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and fed condition in healthy male subjects
- To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under fed condition in healthy male subjects
- To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in Korean healthy male subjects
Detailed description
Phase I Study divided into 3 parts written as bellows.
Part I. Lozanoc 50mg single dose under fed condition vs Part 2. Lozanoc 50mg single dose under fasted condition vs Part 3. Sporanox 100mg single dose under fed condition
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lozanoc 50mg | Experimental | Drug: Lozanoc 50mgLozanoc 50mg, oral administration |
| Sporanox 100mg | Active comparator | Drug: Sporanox 100mgSporanox 100mg, oral administration |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Korean male volunteers in the age between 19 and 50 years old (inclusive)
- Subject who are able to give signed informed consent
- Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighting at least 50kg
- Subject who are considered
- Agree to continue to use at least two accepted methods of birth control and not to donate sperm for at least 1 days before the first dosing, during the course of the study and for a period of 90days following the last dosing.
Key exclusion criteria (14 listed)
- History of allergy or sensitivity to any drug, including any prior serious adverse reaction to antifungal agent(s)
- History of congestive heart failure or Patients with ventricular dysfunction such as congestive heart failure
- Undergone surgery or who have a medical condition, that in the judgment of the Investigator, may affect absorption, distribution, metabolism or elimination of the drug product
- Participated in a previous clinical trial within 90 days prior to screening visit
- Donated blood or had a significant loss of blood within 60 days prior to screening visit
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 |
|---|---|---|
| Lozanoc 50mgLozanoc 50mg single dose under fed and fasted condition | Drug | Lozanoc 50mg |
| Sporanox 100mgSporanox 100mg single dose under fed condition | Drug | Sporanox 100mg |
Primary outcome
Cmax
Time frame: 0~120 hour after medication
2 secondary outcomes
tmax
Time frame: 0~120 hour after medication
AUCinf
Time frame: 0~120 hour after medication
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 4 Mar 2016.
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.
Kyun-Seop Bae, M.D., Ph.D. principal investigator
Department of Clinical Pharmacology and Therapeutics, Asan Medical Center
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 Lozanoc 50mg and Sporanox 100mg in people with Superficial Mycoses and Dermatomycoses, run by Boryung Pharmaceutical Co., Ltd 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 13 inclusion and 14 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 4 Mar 2016. 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?
Cmax (time frame: 0~120 hour after medication). 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 4 Mar 2016.