OnychomycosisPhase 1NCT01841996
Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients
A Phase 1 study testing ME1111 solution in people with Onychomycosis, run by Meiji Seika Pharma Co., Ltd. at 2 sites in United States.
Trial summary
This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study. The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in adults with distal subungual onychomycosis of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- ME1111 solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Aug 2013
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of any race and between the ages of 18 and 70 inclusive
- Clinically diagnosed onychomycosis of the target nail
- Presence of moderate to severe distal subungual onychomycosis
- A positive potassium hydroxide(KOH) microscopy test result
- A positive fungal culture for a dermatophyte
- Females of childbearing potential must be using a highly effective method of birth control and be willing to remain on the same method of birth control throughout the study
- Good general health as determined by the Investigator based on the subject's medical history and physical examination
Who cannot join
- Clinical significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize subject's safety
- Subjects with a history of diabetes mellitus
- Unwilling to refrain from the use of nail cosmetics such as clear and/or colored nail solutions
- Females who are nursing, pregnant, or planning a pregnancy during the study
- Failure to complete the specified washout period(s) for the following topical medications: Antifungals drugs within 4 weeks; Anti-inflammatory drugs, corticosteroids, immunomodulators within 2 weeks
- Failure to complete the specified washout period(s) for the following systemic medications: Corticosteroids within 2 weeks; Antifungals for treatment of onychomycosis or any antifungal with known activity against dermatophyte within the previous 24 weeks or 5 half-lives of the drug, whichever is longer; Immunomodulators within 4 weeks
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- History of cardiac disease and cardiac arrhythmic activity, or prolonged QT interval
- Received treatment for any type of cancer within the last 6 months
- History of any significant disease or disorder that might put subjects at risk by participating in study or influence results of study
- Nail or anatomic abnormalities of the toe
- Positive test for HIV, Hepatitis B or Hepatitis C
- History of street drug or alcohol abuse
- Donated or lost blood or participated in a clinical study which involved the withdrawal of a large volume of blood (500 mL or more), within the last 6-week
- Participated in any other trial of an investigational drug or device within 30 days or 5 half-lives of the investigational drug or participation in a research study concurrent with this study
- Unable to communicate or cooperate with the Investigator due to comprehension, mental development, or impaired cerebral function
- Presence of any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating on the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Austin, Texas
Study site
College Station, Texas
About this study
Official title: A Phase 1 Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study of the Safety, Absorption and Systemic Pharmacokinetics of ME1111 Topical Agent Applied to All Toenails of Adult Moderate to Severe Onychomycosis Patients for 28 Days
This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study.
The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in adults with distal subungual onychomycosis of the toenails.
- Conditions
- Onychomycosis
- Being tested
- ME1111 solution, Vehicle Solution
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME1111 solutionDrug
Once a day for 28 days
Vehicle SolutionDrug
Once a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| ME1111 solution | Experimental | Not described Receives: Drug: ME1111 solution |
| Vehicle Solution | Placebo comparator | Not described Receives: Drug: Vehicle Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events observed throughout the study period.
Measured: from Baseline to Day 57
Application site reactions will be evaluated using categorical scales for signs and symptoms throughout the study period.
Measured: from Baseline to Day 57
Area under the plasma concentration of ME1111 will be assessed based on the analysis of blood samples over 24 hours
Measured: Day 1, 28
Urinary excretion rate will be assessed based on the analysis of urinary samples over 24 hours
Measured: Day 1, 28
Plasma trough levels of ME1111
Measured: Day 4, 8, 15, 22, 25, 43, 57
Secondary outcomes (4)
Area under the nail concentration of ME1111
Measured: Day 2, 15, 29, 57
The proportion of subjects who achieve negative KOH microscopy testing results
Measured: Day 29, 57
The proportion of subjects who achieve negative fungal culture results
Measured: Day 29, 57
The change from baseline in linear toenail growth at Days 29 and 57 will be analyzed
Measured: Day 1, 29, 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitsuharu Egawa, Study chair, Meiji Seika Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841996
- Sponsor's protocol ID
- ME1111-1
- Status last verified
- Dec 2013
- First submitted
- 18 Apr 2013
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study of the Safety, Absorption and Systemic Pharmacokinetics of ME1111 Topical Agent Applied to All Toenails of Adult Moderate to Severe Onychomycosis Patients for 28 Days
- ClinicalTrials.gov ID
- NCT01841996
- Acronym / sponsor ID
- ME1111-1
- Conditions
- Onychomycosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- First posted
- 29 Apr 2013 (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.
This study is Randomized, Double-Blind, Vehicle-Controlled, Multiple-Dose Study.
The purpose is to determine the safety, tolerability, systemic exposure and pharmacokinetics of ME1111 after repeated daily topical application of ME1111 in a maximal use setting in adults with distal subungual onychomycosis of the toenails.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ME1111 solution | Experimental | Drug: ME1111 solution |
| Vehicle Solution | Placebo comparator | Drug: Vehicle Solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female of any race and between the ages of 18 and 70 inclusive
- Clinically diagnosed onychomycosis of the target nail
- Presence of moderate to severe distal subungual onychomycosis
- A positive potassium hydroxide(KOH) microscopy test result
- A positive fungal culture for a dermatophyte
Key exclusion criteria (16 listed)
- Clinical significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize subject's safety
- Subjects with a history of diabetes mellitus
- Unwilling to refrain from the use of nail cosmetics such as clear and/or colored nail solutions
- Females who are nursing, pregnant, or planning a pregnancy during the study
- Failure to complete the specified washout period(s) for the following topical medications: Antifungals drugs within 4 weeks; Anti-inflammatory drugs, corticosteroids, immunomodulators within 2 weeks
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 |
|---|---|---|
| ME1111 solutionOnce a day for 28 days | Drug | ME1111 solution |
| Vehicle SolutionOnce a day for 28 days | Drug | Vehicle Solution |
Primary outcome
The number of adverse events observed throughout the study period.
Time frame: from Baseline to Day 57
Application site reactions will be evaluated using categorical scales for signs and symptoms throughout the study period.
Time frame: from Baseline to Day 57
Area under the plasma concentration of ME1111 will be assessed based on the analysis of blood samples over 24 hours
Time frame: Day 1, 28
Urinary excretion rate will be assessed based on the analysis of urinary samples over 24 hours
Time frame: Day 1, 28
Plasma trough levels of ME1111
Time frame: Day 4, 8, 15, 22, 25, 43, 57
4 secondary outcomes
Area under the nail concentration of ME1111
Time frame: Day 2, 15, 29, 57
The proportion of subjects who achieve negative KOH microscopy testing results
Time frame: Day 29, 57
The proportion of subjects who achieve negative fungal culture results
Time frame: Day 29, 57
The change from baseline in linear toenail growth at Days 29 and 57 will be analyzed
Time frame: Day 1, 29, 57
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 17 Dec 2013.
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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.
Mitsuharu Egawa study chair
Meiji Seika Pharma Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ME1111 solution in people with Onychomycosis, run by Meiji Seika Pharma Co., Ltd. at 2 sites in United States.
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 7 inclusion and 16 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 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
The number of adverse events observed throughout the study period. (time frame: from Baseline to Day 57). The study lists 5 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 17 Dec 2013.