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Trial record 1 of 1 for:    NCT00679601
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Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)

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ClinicalTrials.gov Identifier: NCT00679601
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 15, 2008
First Posted Date  ICMJE May 19, 2008
Last Update Posted Date February 20, 2018
Actual Study Start Date  ICMJE March 31, 2007
Actual Primary Completion Date May 31, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
Plasma concentration of AN2690 in plasma and the concentration of AN2690 in urine over time [ Time Frame: Days 0, 1, 14, 15, and 28 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
  • Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail growth [ Time Frame: Days 0, 14, 28, and 42 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME II)
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE Drug: AN2690
AN2690 7.5% Solution, once daily for 28 days
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2008)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 31, 2007
Actual Primary Completion Date May 31, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00679601
Other Study ID Numbers  ICMJE AN2690-ONYC-205
C3371014 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP