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

Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841996
• Other study ID #: ME1111-1
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2013
• Last updated: December 15, 2013
• Start date: March 2013

Study information

• Verified date: December 2013
• Source: Meiji Seika Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• ME1111 solution
Once a day for 28 days
• Vehicle Solution
Once a day for 28 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meiji Seika Pharma Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of adverse events observed throughout the study period.		from Baseline to Day 57	Yes
Primary	Application site reactions will be evaluated using categorical scales for signs and symptoms throughout the study period.		from Baseline to Day 57	Yes
Primary	Area under the plasma concentration of ME1111 will be assessed based on the analysis of blood samples over 24 hours		Day 1, 28	No
Primary	Urinary excretion rate will be assessed based on the analysis of urinary samples over 24 hours		Day 1, 28	No
Primary	Plasma trough levels of ME1111		Day 4, 8, 15, 22, 25, 43, 57	No
Secondary	Area under the nail concentration of ME1111		Day 2, 15, 29, 57	No
Secondary	The proportion of subjects who achieve negative KOH microscopy testing results		Day 29, 57	No
Secondary	The proportion of subjects who achieve negative fungal culture results		Day 29, 57	No
Secondary	The change from baseline in linear toenail growth at Days 29 and 57 will be analyzed		Day 1, 29, 57	No