Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)
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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.
Condition or disease
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.
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female ≥18 and ≤65
BMI between 18.5 and 35 inclusive
Moderate to severe onychomycosis involving ≥80% of both great toenails, as determined by visual inspection after the nail has been trimmed
Combined thickness of the nail plate and nail bed of each great toenail is >3mm
At least 6 additional toenails with a clinical diagnosis of onychomycosis
If a female of childbearing potential, must be using of a highly effective method of birth control or abstinence and be willing to remain on that same method of birth control throughout the study
Capable of understanding and signing the informed consent, and willing to comply with all requirements of the study
History of allergy to any of the study drug 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
Willing 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
Failure to complete the specified washout period(s) for the following topical:
Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks