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
About this trial
This is an interventional screening trial for Onychomycosis focused on measuring Onychomycosis, Open Label, PK
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.
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
NCT ID
NCT01790165
First Posted
March 18, 2010
Last Updated
February 11, 2013
Sponsor
Celtic Pharma Development Services
Collaborators
PPD
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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