TDT 067 Open Label Multi-Dose Onychomycosis Study

Trial end date:
Target enrollment:
Participant gender:
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.
Phase 2
Accepts Healthy Volunteers?
Lead Sponsor:
Celtic Pharma Development Services
Inclusion Criteria:

- Subjects must be between 18 and 65 years of age inclusive, of any race, and of either

- 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

- 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

- 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

- 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.