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TDT 067 Open Label Multi-Dose Onychomycosis Study

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
TDT067 and Lamisil
Sponsored by
Celtic Pharma Development Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Onychomycosis focused on measuring Onychomycosis, Open Label, PK

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must be between 18 and 65 years of age inclusive, of any race, and of either sex.
  • Male subjects only: Male subjects must use a reliable form of contraception during their participation in the trial and for 3 months after their last dose of study drug.
  • Female subjects only: Either of non-childbearing potential (i.e. either surgically sterilized or post menopausal) or must be using adequate contraception, have a negative pregnancy test prior to start of dosing, and must agree to continue to use this method of contraception until 3 months after the last dose. Acceptable contraceptive methods are oral contraceptive, IUD, or diaphragm with spermicide (unless anatomically sterile).
  • Subjects must be in good general health as confirmed by a medical history and physical examination.
  • Subjects must have 2 big toes with nails that have the potential to be clipped to provide nail samples.
  • Subjects must have clinically diagnosed distal subungual onychomycosis of the toenails; at least 5 nails in total must present with onychomycotic signs (onycholysis, subungual hyperkeratosis) including extensive involvement (≥50%) of both large nails and mycological confirmation (positive KOH microscopy) from 1 of the large nails.
  • Subject must sign a statement of informed consent.
  • Subjects must be able to understand the requirements of the study, abide by the restriction, and return for all of the required examinations

Exclusion Criteria:

  • Subjects lacking any toes.
  • Subjects with known hypersensitivity to terbinafine or any of the excipients in the TDT 067.
  • Subjects with symptomatic tinea pedis requiring treatment.
  • Subjects with any medical, neurological, or psychiatric conditions that in the opinion of the Investigator would make the subject unsuitable for enrollment onto the study.
  • Subjects with chronic or active liver disease, as well as subjects with elevated liver function tests above normal for the testing laboratory.
  • Subjects with renal impairment (creatinine clearance ≤50 mL/min).
  • Subjects who have received terbinafine tablets within 12 months or topical terbinafine (cream, solution/spray, or gel) within 6 months prior to screening visit; subjects who have received other oral antifungals within 4 months or other topical antifungals within 1 month.
  • Subjects who have participated within the previous 3 months in a clinical trial for the systemic or topical treatment of onychomycosis.
  • Subjects being treated with rifampin or cimetidine.
  • Subjects being treated with an investigational drug within 1 month prior to study start.
  • Subjects with psoriasis or history of psoriasis.
  • Subjects with nail dystrophy or other nail abnormalities other than onychomycosis.
  • Subjects with serious concurrent disease that might prevent completion of the trial.
  • Subjects who are pregnant (confirmed by pregnancy test) or who plan to become pregnant within the study timeframe or who are nursing.
  • Subjects who cannot read, understand, or sign the informed consent form or the instructions for applying and removing the study formulations.
  • Subjects who cannot apply the product to their toenails.
  • Subjects who do not wish to provide nail clippings.
  • Subjects who cannot or will not provide adequate blood and urine samples.
  • Subjects using any nail polish products or other nail cosmetic products on any of the toenails designated for treatment within 7 days prior to the start of treatment and who are unwilling to discontinue use of these products for the duration of this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    TDT067

    Placebo

    Arm Description

    Active treatment

    Placebo

    Outcomes

    Primary Outcome Measures

    PK
    Cmax, Tmax, AUC0-12, AUC0-24, Cmax Ratio (day 28/day 35) were evaluated

    Secondary Outcome Measures

    Full Information

    First Posted
    March 18, 2010
    Last Updated
    February 11, 2013
    Sponsor
    Celtic Pharma Development Services
    Collaborators
    PPD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01790165
    Brief Title
    TDT 067 Open Label Multi-Dose Onychomycosis Study
    Official Title
    A Phase II Open Label Multiple-Dose Study of the Safety and Pharmacokinetics of TDT 067 Under Conditions of Maximal Use in Subjects With Distal Subungual Onychomycosis of the Toenails
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2009 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    June 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Celtic Pharma Development Services
    Collaborators
    PPD

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to establish a clinical bridge to Lamisil® tablets by conducting a clinical pharmacokinetic (PK) study comparing the systemic exposure of a Lamisil® tablet with that of with TDT 067 under maximal use conditions. Under maximal use conditions in onychomycotic subjects, the aim is to confirm that there are significantly lower plasma levels of terbinafine and its major metabolites after a topical administration of TDT 067 for 28 days in comparison with a single oral 250 mg Lamisil® tablet.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Onychomycosis
    Keywords
    Onychomycosis, Open Label, PK

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    27 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TDT067
    Arm Type
    Experimental
    Arm Description
    Active treatment
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    TDT067 and Lamisil
    Other Intervention Name(s)
    Lamisil
    Intervention Description
    Topical administration of TDT067 and single oral administration of 250 mg Lamisil tablet
    Primary Outcome Measure Information:
    Title
    PK
    Description
    Cmax, Tmax, AUC0-12, AUC0-24, Cmax Ratio (day 28/day 35) were evaluated
    Time Frame
    35 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must be between 18 and 65 years of age inclusive, of any race, and of either sex. Male subjects only: Male subjects must use a reliable form of contraception during their participation in the trial and for 3 months after their last dose of study drug. Female subjects only: Either of non-childbearing potential (i.e. either surgically sterilized or post menopausal) or must be using adequate contraception, have a negative pregnancy test prior to start of dosing, and must agree to continue to use this method of contraception until 3 months after the last dose. Acceptable contraceptive methods are oral contraceptive, IUD, or diaphragm with spermicide (unless anatomically sterile). Subjects must be in good general health as confirmed by a medical history and physical examination. Subjects must have 2 big toes with nails that have the potential to be clipped to provide nail samples. Subjects must have clinically diagnosed distal subungual onychomycosis of the toenails; at least 5 nails in total must present with onychomycotic signs (onycholysis, subungual hyperkeratosis) including extensive involvement (≥50%) of both large nails and mycological confirmation (positive KOH microscopy) from 1 of the large nails. Subject must sign a statement of informed consent. Subjects must be able to understand the requirements of the study, abide by the restriction, and return for all of the required examinations Exclusion Criteria: Subjects lacking any toes. Subjects with known hypersensitivity to terbinafine or any of the excipients in the TDT 067. Subjects with symptomatic tinea pedis requiring treatment. Subjects with any medical, neurological, or psychiatric conditions that in the opinion of the Investigator would make the subject unsuitable for enrollment onto the study. Subjects with chronic or active liver disease, as well as subjects with elevated liver function tests above normal for the testing laboratory. Subjects with renal impairment (creatinine clearance ≤50 mL/min). Subjects who have received terbinafine tablets within 12 months or topical terbinafine (cream, solution/spray, or gel) within 6 months prior to screening visit; subjects who have received other oral antifungals within 4 months or other topical antifungals within 1 month. Subjects who have participated within the previous 3 months in a clinical trial for the systemic or topical treatment of onychomycosis. Subjects being treated with rifampin or cimetidine. Subjects being treated with an investigational drug within 1 month prior to study start. Subjects with psoriasis or history of psoriasis. Subjects with nail dystrophy or other nail abnormalities other than onychomycosis. Subjects with serious concurrent disease that might prevent completion of the trial. Subjects who are pregnant (confirmed by pregnancy test) or who plan to become pregnant within the study timeframe or who are nursing. Subjects who cannot read, understand, or sign the informed consent form or the instructions for applying and removing the study formulations. Subjects who cannot apply the product to their toenails. Subjects who do not wish to provide nail clippings. Subjects who cannot or will not provide adequate blood and urine samples. Subjects using any nail polish products or other nail cosmetic products on any of the toenails designated for treatment within 7 days prior to the start of treatment and who are unwilling to discontinue use of these products for the duration of this study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eduardo Tschen, MD
    Organizational Affiliation
    Academic Dermatology Assoc
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    TDT 067 Open Label Multi-Dose Onychomycosis Study

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