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

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

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.

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