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Trial record 14 of 40 for:    Terbinafine

TDT 067 Open Label Multi-Dose Onychomycosis Study

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. Identifier: NCT01790165
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : February 13, 2013
Information provided by (Responsible Party):
Celtic Pharma Development Services

Tracking Information
First Submitted Date  ICMJE March 18, 2010
First Posted Date  ICMJE February 13, 2013
Last Update Posted Date February 13, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2013)
PK [ Time Frame: 35 days ]
Cmax, Tmax, AUC0-12, AUC0-24, Cmax Ratio (day 28/day 35) were evaluated
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE TDT 067 Open Label Multi-Dose Onychomycosis Study
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Onychomycosis
Intervention  ICMJE Drug: TDT067 and Lamisil
Topical administration of TDT067 and single oral administration of 250 mg Lamisil tablet
Other Name: Lamisil
Study Arms  ICMJE
  • Experimental: TDT067
    Active treatment
    Intervention: Drug: TDT067 and Lamisil
  • Placebo Comparator: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2013)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01790165
Other Study ID Numbers  ICMJE CL-067-II-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celtic Pharma Development Services
Study Sponsor  ICMJE Celtic Pharma Development Services
Collaborators  ICMJE PPD
Investigators  ICMJE
Principal Investigator: Eduardo Tschen, MD Academic Dermatology Assoc
PRS Account Celtic Pharma Development Services
Verification Date February 2013

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