Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I)
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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.
Condition or disease
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.
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail [ Time Frame: Days 0, 14, 28, 42, 84, 120, 150, 180, 240, 300, and 360 ]
Secondary Outcome Measures :
Safety and tolerance assessed by application site reactions, adverse events, laboratory tests, vital signs, physical examinations, and 12-lead EKG [ Time Frame: Days 0-28, 42, 84, 120, 150, 180, 240, 300, and 360 ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
A witnessed, signed informed consent approved by Institutional Review Board
Male or female of any race at least 18 years of age but not older than 65 years of age at the time of screening
Body Mass Index between 18.5 and 35, inclusive
Onychomycosis involving > 80% of both great toenails, as determined by visual inspection after the nail has been trimmed
Each great toenail possess a combined thickness of the nail plate and nail bed > 3 mm
At least six additional toenails with clinical diagnosis of onychomycosis
A positive KOH wet mount for at least one great toenail
If subject is a female of childbearing potential, must be using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
Considered reliable and capable of understanding his/her responsibility and role in the study
History of allergy to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure
Clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety
Diabetes mellitus requiring treatment other than diet and exercise
Unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study
Nursing, pregnant or planning to become pregnant during the study
Has not undergone the specified washout period(s) for the following topical preparations or does the subject require the concurrent use of any of the following topical medications:
Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study: 4 weeks