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

NCT01841996 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-12-17

No results posted yet for this study

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

Interventions

DRUG

ME1111 solution

Once a day for 28 days

DRUG

Vehicle Solution

Once a day for 28 days

Sponsors & Collaborators

  • Meiji Seika Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Mitsuharu Egawa · Meiji Seika Pharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01841996 on ClinicalTrials.gov