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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Topica Pharmaceuticals
• Treatments: Luliconazole; Pharmaceutical Solutions

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