Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)
The purpose of the study is to determine the absorption and systemic pharmacokinetics of AN2690 following daily application to all ten (10) toenails for 28 days.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Plasma concentration of AN2690 in plasma and the concentration of AN2690 in urine over time [ Time Frame: Days 0, 1, 14, 15, and 28 ] [ Designated as safety issue: No ]
- Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail growth [ Time Frame: Days 0, 14, 28, and 42 ] [ Designated as safety issue: No ]
- Safety and tolerance assessed by application site reactions, adverse events, vital signs, physical examinations, and 12-lead EKG [ Time Frame: Days 0-28, and 42 ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2007|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
A single center, open-label, multiple-dose study design will be used. Planned enrollment is 20 subjects to complete 15. Subjects must have a clinical diagnosis of onychomycosis of each great toenail and a clinical diagnosis of onychomycosis of six of the remaining toenails.