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

NCT ID: NCT01841996

Last Updated: 2013-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31

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.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ME1111 solution

Group Type: EXPERIMENTAL

ME1111 solution

Intervention Type: DRUG

Once a day for 28 days

Vehicle Solution

Group Type: PLACEBO_COMPARATOR

Vehicle Solution

Intervention Type: DRUG

Once a day for 28 days

Interventions

ME1111 solution

Once a day for 28 days

Intervention Type: DRUG

Vehicle Solution

Once a day for 28 days

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meiji Seika Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitsuharu Egawa

Role: STUDY_CHAIR

Meiji Seika Pharma Co., Ltd.

Locations

Austin, Texas, United States

College Station, Texas, United States

Countries

United States

Other Identifiers

ME1111-1

Identifier Type: -

Identifier Source: org_study_id