Open-Label Pharmacokinetics (PK)/Safety Study of Luliconazole Solution, 10% in Distal Subungual Onychomycosis

Study Overview
=================
Brief Summary
-----------------
To determine the safety, tolerability, systemic exposure and pharmacokinetics of luliconazole after repeat daily topical application of Luliconazole Solution, 10% in a maximal use setting in adults with distal subungual onychomycosis of the toenails.

Official Title
-----------------
A Phase 1/2a, Open-Label Study Evaluating the Pharmacokinetics, Safety and Tolerability of Luliconazole Solution, 10% in Subjects With Moderate to Severe Distal Subungual Onychomycosis

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: Luliconazole Solution, 10%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years Distal Subungual Onychomycosis(DSO)on both great toenails with >=50%involvement of at least 1 great toenail At least 4 additional toenails with DSO Positive KOH and culture Normal renal and hepatic function Exclusion Criteria: Subjects with hypersensitivity to imidazole compounds or any other ingredient Subjects unwilling to refrain from use of nail cosmetics until end of study Subjects with symptomatic tinea pedis Subjects with any history of cardiac disease of cardiac rhythm abnormalities Female subjects who are pregnant, nursing, or planning a pregnancy Subjects who have not undergone the specified washout period(s) for the following or requiring the concurrent use of: topical antifungal within 4 weeks; topical anti-inflammatory, corticosteroids, topical immunomodulators within 2 weeks; systemic corticosteroids within 2 weeks; systemic immunomodulators within 4 weeks. Subjects receiving systemic antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes within the previous 12 weeks or 5 half-lives of the drug, whichever is longer Subjects receiving any other treatment/therapy for the onychomycosis not previously mentioned (e.g., laser treatment) within 4 weeks Subjects with a history of significant internal disease or with a life threatening condition within the last 6 months Subjects with anatomic abnormalities of the toe(s) and or toenails Subject who have donated or lost a large volume of blood ( 500 mL or more, during the previous 6 weeks Subjects with a recent history of or currently known to abuse drugs or alcohol Subjects currently participating in another investigational medication or device study or have participated in a clinical trial within 30 days or five half-lives of the test medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luliconazole Solution, 10%<br> | Drug: Luliconazole Solution, 10%<br>* 28 days of daily application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters (AUC, Cmax, Tmax, t1/2) will be measured at days 1 (Baseline), 9, 15 and 29. Safety assessments include monitoring of adverse events, local site tolerability, ECG monitoring, and changes in laboratory values and vital signs. |  | March 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of linear toenail growth. |  | March 2011 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toenail, Fungal Infections, DSO