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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meiji Seika Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01841996
First received: April 18, 2013
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: ME1111 solution
Drug: Vehicle Solution
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Meiji Seika Pharma Co., Ltd.:

Primary Outcome Measures:
  • The number of adverse events observed throughout the study period. [ Time Frame: from Baseline to Day 57 ] [ Designated as safety issue: Yes ]
  • Application site reactions will be evaluated using categorical scales for signs and symptoms throughout the study period. [ Time Frame: from Baseline to Day 57 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Urinary excretion rate will be assessed based on the analysis of urinary samples over 24 hours [ Time Frame: Day 1, 28 ] [ Designated as safety issue: No ]
  • Plasma trough levels of ME1111 [ Time Frame: Day 4, 8, 15, 22, 25, 43, 57 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the nail concentration of ME1111 [ Time Frame: Day 2, 15, 29, 57 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve negative KOH microscopy testing results [ Time Frame: Day 29, 57 ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve negative fungal culture results [ Time Frame: Day 29, 57 ] [ Designated as safety issue: No ]
  • The change from baseline in linear toenail growth at Days 29 and 57 will be analyzed [ Time Frame: Day 1, 29, 57 ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ME1111 solution Drug: ME1111 solution
Once a day for 28 days
Placebo Comparator: Vehicle Solution Drug: Vehicle Solution
Once a day for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841996

Locations
United States, Texas
Austin, Texas, United States
College Station, Texas, United States
Sponsors and Collaborators
Meiji Seika Pharma Co., Ltd.
Investigators
Study Chair: Mitsuharu Egawa Meiji Seika Pharma Co., Ltd.
  More Information

No publications provided

Responsible Party: Meiji Seika Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01841996     History of Changes
Other Study ID Numbers: ME1111-1
Study First Received: April 18, 2013
Last Updated: December 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 10, 2014