- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00679601
Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)
February 16, 2018 updated by: Pfizer
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
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 Overview
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Bryan, Texas, United States, 77802
- J&S Studies
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
- Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
Failure to complete the specified washout period(s) for the following systemic medications:
- Corticosteroids (including intramuscular injections): 2 weeks
- Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 24 weeks
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma concentration of AN2690 in plasma and the concentration of AN2690 in urine over time
Time Frame: Days 0, 1, 14, 15, and 28
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Days 0, 1, 14, 15, and 28
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail growth
Time Frame: Days 0, 14, 28, and 42
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Days 0, 14, 28, and 42
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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
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Days 0-28, and 42
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2007
Primary Completion (Actual)
May 31, 2007
Study Completion (Actual)
May 31, 2007
Study Registration Dates
First Submitted
May 15, 2008
First Submitted That Met QC Criteria
May 15, 2008
First Posted (Estimate)
May 19, 2008
Study Record Updates
Last Update Posted (Actual)
February 20, 2018
Last Update Submitted That Met QC Criteria
February 16, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN2690-ONYC-205
- C3371014 (Other Identifier: Alias Study Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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