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

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
J&S Studies
Bryan, Texas, 77802 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Onychomycosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00679601
Pfizer
Completed
Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)

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Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)
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.
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.
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Onychomycosis
Drug: AN2690
AN2690 7.5% Solution, once daily for 28 days
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2007
May 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00679601
AN2690-ONYC-205
No
Not Provided
Not Provided
Karl Beutner, MD, PhD, Chief Medical Officer, Anacor Pharmaceuticals, Inc.
Pfizer
Not Provided
Study Director: Karl Beutner, MD, PhD Pfizer
Pfizer
May 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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