Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II) - Full Text View

Sponsored by:	Anacor Pharmaceuticals, Inc.
Information provided by:	Anacor Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00679601

Purpose

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

Drug Information available for: AN 2690

U.S. FDA Resources

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

Further study details as provided by Anacor Pharmaceuticals, Inc.:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

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)

Intervention Details:

AN2690 7.5% Solution, once daily for 28 days

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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:
1. Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
2. Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
Failure to complete the specified washout period(s) for the following systemic medications:
1. Corticosteroids (including intramuscular injections): 2 weeks
2. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 24 weeks
3. Systemic immunomodulators: 4 weeks
Received treatment of any type for cancer within the last 6 months
History of any significant internal disease
Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated
AIDS or AIDS related complex
History of street drug or alcohol abuse
Donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six-week period preceding study initiation
Donated plasma during the two week period preceding study initiation
Participated in any other trial of an investigational drug or device within 30 days prior to enrollment or participation in a research study concurrent with this study
Prior enrollment in a study using the study drug, AN2690

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679601

Locations

United States, Texas
J&S Studies
Bryan, Texas, United States, 77802

Sponsors and Collaborators

Anacor Pharmaceuticals, Inc.

Investigators

Study Director:

Karl Beutner, MD, PhD

Anacor Pharmaceuticals, Inc.

More Information

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by Anacor Pharmaceuticals, Inc.:

Onychomycosis
Fungal Nail

Study placed in the following topic categories:

Mycoses
Skin Diseases, Infectious
Onychomycosis

Skin Diseases
Tinea
Dermatomycoses

Additional relevant MeSH terms:

Nail Diseases
Infection

ClinicalTrials.gov processed this record on January 15, 2009