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

NCT01841996 | Completed Phase 1

• 1 other identifier: ME1111-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (5)

• The number of adverse events observed throughout the study period.

  from Baseline to Day 57

• Application site reactions will be evaluated using categorical scales for signs and symptoms throughout the study period.

  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

  Day 1, 28

• Urinary excretion rate will be assessed based on the analysis of urinary samples over 24 hours

  Day 1, 28

• Plasma trough levels of ME1111

  Day 4, 8, 15, 22, 25, 43, 57

Secondary Outcomes (4)

• 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

Study Arms (2)

ME1111 solution

EXPERIMENTAL

Drug: ME1111 solution

Vehicle Solution

PLACEBO COMPARATOR

Drug: Vehicle Solution

Interventions

ME1111 solution DRUG

Once a day for 28 days

ME1111 solution

Vehicle Solution DRUG

Once a day for 28 days

Vehicle Solution

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meiji Seika Pharma Co., Ltd.: lead

Study Sites (2)

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

College Station, Texas, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mitsuharu Egawa

  Meiji Seika Pharma Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 29, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (2)