NCT01841996
Completed
Phase 1
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
ConditionsOnychomycosis
Overview
- Phase
- Phase 1
- Intervention
- ME1111 solution
- Conditions
- Onychomycosis
- Sponsor
- Meiji Seika Pharma Co., Ltd.
- Enrollment
- 24
- Primary Endpoint
- The number of adverse events observed throughout the study period.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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 toenails.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Arms & Interventions
ME1111 solution
Intervention: ME1111 solution
Vehicle Solution
Intervention: Vehicle Solution
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Area under the nail concentration of ME1111(Day 2, 15, 29, 57)
- The proportion of subjects who achieve negative KOH microscopy testing results(Day 29, 57)
- The proportion of subjects who achieve negative fungal culture results(Day 29, 57)
- The change from baseline in linear toenail growth at Days 29 and 57 will be analyzed(Day 1, 29, 57)
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