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

NCT01044381 | Completed Phase 1

• 1 other identifier: TP-0901-S
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis

Keywords

Toenail; Fungal Infections; DSO

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of linear toenail growth.

  March 2011

Study Arms (1)

Luliconazole Solution, 10%

EXPERIMENTAL

Drug: Luliconazole Solution, 10%

Interventions

Luliconazole Solution, 10% DRUG

28 days of daily application

Luliconazole Solution, 10%

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Topica Pharmaceuticals: lead

Study Sites (1)

J&S Studies

College Station, Texas, 77840, United States

Location

MeSH Terms

Conditions

Onychomycosis; Mycoses

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Terry M Jones, M.D.

  J&S Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 7, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

US (1)