ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: AN2690 Phase 2

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  (Clinical Trial)
Actual Enrollment : 20 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 31, 2007
Actual Primary Completion Date : May 31, 2007
Actual Study Completion Date : May 31, 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Tavaborole


Intervention Details:
  • Drug: AN2690
    AN2690 7.5% Solution, once daily for 28 days


Primary Outcome Measures :
  1. Plasma concentration of AN2690 in plasma and the concentration of AN2690 in urine over time [ Time Frame: Days 0, 1, 14, 15, and 28 ]

Secondary Outcome Measures :
  1. Efficacy measures of linear toenail growth, fungal culture results, KOH results, and clear toenail growth [ Time Frame: Days 0, 14, 28, and 42 ]
  2. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679601


Locations
United States, Texas
J&S Studies
Bryan, Texas, United States, 77802
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00679601     History of Changes
Other Study ID Numbers: AN2690-ONYC-205
C3371014 ( Other Identifier: Alias Study Number )
First Posted: May 19, 2008    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Keywords provided by Pfizer:
Onychomycosis
Fungal Nail

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Tavaborole
Antifungal Agents
Anti-Infective Agents