Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients

Meiji Seika Pharma

Status and phase: Completed; Phase 1

Conditions: Onychomycosis

Treatments: Drug: ME1111 solution; Drug: Vehicle Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01841996

ME1111-1

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female of any race and between the ages of 18 and 70 inclusive
2. Clinically diagnosed onychomycosis of the target nail
3. Presence of moderate to severe distal subungual onychomycosis
4. A positive potassium hydroxide(KOH) microscopy test result
5. A positive fungal culture for a dermatophyte
6. 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
7. Good general health as determined by the Investigator based on the subject's medical history and physical examination

Exclusion criteria

1. Clinical significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize subject's safety
2. Subjects with a history of diabetes mellitus
3. Unwilling to refrain from the use of nail cosmetics such as clear and/or colored nail solutions
4. Females who are nursing, pregnant, or planning a pregnancy during the study
5. 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
6. 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
7. History of cardiac disease and cardiac arrhythmic activity, or prolonged QT interval
8. Received treatment for any type of cancer within the last 6 months
9. History of any significant disease or disorder that might put subjects at risk by participating in study or influence results of study
10. Nail or anatomic abnormalities of the toe
11. Positive test for HIV, Hepatitis B or Hepatitis C
12. History of street drug or alcohol abuse
13. 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
14. 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
15. Unable to communicate or cooperate with the Investigator due to comprehension, mental development, or impaired cerebral function
16. Presence of any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subjects safety while participating on the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

ME1111 solution

Experimental group

Treatment:

Drug: ME1111 solution

Vehicle Solution

Placebo Comparator group

Treatment:

Drug: Vehicle Solution