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Sponsored by: |
Anacor Pharmaceuticals, Inc. |
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Information provided by: | Anacor Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00679601 |
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 | Intervention | Phase |
---|---|---|
Onychomycosis |
Drug: AN2690 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
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 |
Enrollment: | 20 |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Failure to complete the specified washout period(s) for the following topical:
Failure to complete the specified washout period(s) for the following systemic medications:
Responsible Party: | Anacor Pharmaceuticals, Inc. ( Karl Beutner, MD, PhD, Chief Medical Officer ) |
Study ID Numbers: | AN2690-ONYC-205 |
Study First Received: | May 15, 2008 |
Last Updated: | May 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00679601 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Onychomycosis Fungal Nail |
Mycoses Skin Diseases, Infectious Nail Diseases Onychomycosis |
Skin Diseases Tinea Dermatomycoses |
Mycoses Skin Diseases, Infectious Nail Diseases Onychomycosis |
Skin Diseases Infection Tinea Dermatomycoses |