Status:
COMPLETED
Pharmacokinetics and Safety Study of ME1111 in Moderate to Severe Onychomycosis Patients
Lead Sponsor:
Meiji Seika Pharma Co., Ltd.
Conditions:
Onychomycosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01841996
Start Date
March 1 2013
Last Update
December 17 2013
Active Locations (2)
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1
Austin, Texas, United States
2
College Station, Texas, United States