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Trial record 1 of 1 for:    NCT00680160
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Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis (ADME I)

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ClinicalTrials.gov Identifier: NCT00680160
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : February 21, 2019
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 21, 2019
Actual Study Start Date  ICMJE April 30, 2006
Actual Primary Completion Date May 9, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail [ Time Frame: Days 0, 14, 28, 42, 84, 120, 150, 180, 240, 300, and 360 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
Safety and tolerance assessed by application site reactions, adverse events, laboratory tests, vital signs, physical examinations, and 12-lead EKG [ Time Frame: Days 0-28, 42, 84, 120, 150, 180, 240, 300, and 360 ]
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 I)
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, systemic pharmacokinetics and accumulation in the nail of AN2690 during a 28 day period of daily application of a 7.5% solution of AN2690 to all 10 toenails of up to 25 otherwise healthy adult patients with onychomycosis.
Detailed Description For this study, the case definition of onychomycosis included moderate to severe distal subungual onychomycosis including subjects with evidence of subungual dermatophytoma or yellow spikes, lateral and proximal onychomycosis and severely dystrophic nail plates. Subjects with only superficial white onychomycosis were excluded. Confirmation of the clinical diagnosis of onychomycosis of at least one great toenail included a positive KOH wet mount.
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)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 9, 2007
Actual Primary Completion Date May 9, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A witnessed, signed informed consent approved by Institutional Review Board
  • Male or female of any race at least 18 years of age but not older than 65 years of age at the time of screening
  • Body Mass Index between 18.5 and 35, inclusive
  • Onychomycosis involving > 80% of both great toenails, as determined by visual inspection after the nail has been trimmed
  • Each great toenail possess a combined thickness of the nail plate and nail bed > 3 mm
  • At least six additional toenails with clinical diagnosis of onychomycosis
  • A positive KOH wet mount for at least one great toenail
  • If subject is a female of childbearing potential, must be using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
  • Considered reliable and capable of understanding his/her responsibility and role in the study

Exclusion Criteria:

  • History of allergy to any of the test product(s) 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
  • Unwilling 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
  • Has not undergone the specified washout period(s) for the following topical preparations or does the subject require the concurrent use of any of the following topical medications:

    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
  • Has not undergone the specified washout period(s) for the following systemic medications or does the subject require the concurrent use of any of 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 60 days prior to enrollment or participation in a research study concurrent with this study
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 NCT00680160
Other Study ID Numbers  ICMJE AN2690-ONYC-202
C3371013 ( 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 2019

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