NCT00680160

Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I)

An Open-label, Multiple-dose Study Of The Absorption And Systemic Pharmacokinetics Of An2690 Applied As A 7.5% Solution To All Toenails Of Adult Patients With Moderate To Severe Onychomycosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the absorption, systemic pharmacokinetics and accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5% solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with onychomycosis.

Detailed description

For this study, the case definition of onychomycosis included moderate to severe distal subungual onychomycosis including subjects with evidence of subungual dermatophytoma or yellow spikes, lateral and proximal onychomycosis and severely dystrophic nail plates. Subjects with only superficial white onychomycosis were excluded. Confirmation of the clinical diagnosis of onychomycosis of at least one great toenail included a positive KOH wet mount.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	AN2690	AN2690 7.5% Solution, once daily for 28 days

Timeline

• Start date: 2006-04-30
• Primary completion: 2007-05-09
• Completion: 2007-05-09
• First posted: 2008-05-19
• Last updated: 2019-02-21

Locations

1 site across 1 country: United States