OnychomycosisPhase 2NCT01790165
TDT 067 Open Label Multi-Dose Onychomycosis Study
A Phase 2 study testing TDT067 and Lamisil in people with Onychomycosis, run by Celtic Pharma Development Services.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- TDT067 and Lamisil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
About this 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
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.
- Conditions
- Onychomycosis
- Being tested
- TDT067 and Lamisil
- Keywords
- Onychomycosis, Open Label, PK
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDT067 and LamisilDrug
Also called Lamisil
Topical administration of TDT067 and single oral administration of 250 mg Lamisil tablet
| Study group | Role | What they receive |
|---|---|---|
| TDT067 | Experimental | Active treatment Receives: Drug: TDT067 and Lamisil |
| Placebo | Placebo comparator | Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK
Cmax, Tmax, AUC0-12, AUC0-24, Cmax Ratio (day 28/day 35) were evaluated
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startDec 2009
- Primary completionJan 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celtic Pharma Development Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Eduardo Tschen, MD, Principal investigator, Academic Dermatology Assoc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790165
- Sponsor's protocol ID
- CL-067-II-02
- Status last verified
- Feb 2013
- First submitted
- 18 Mar 2010
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01790165
- Acronym / sponsor ID
- CL-067-II-02
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Open Label, PK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Celtic Pharma Development ServicesIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- Dec 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TDT067 | Experimental | Drug: TDT067 and LamisilActive treatment |
| Placebo | Placebo comparator | –Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDT067 and LamisilAlso: LamisilTopical administration of TDT067 and single oral administration of 250 mg Lamisil tablet | Drug | TDT067 |
Primary outcome
PK
Time frame: 35 days
Cmax, Tmax, AUC0-12, AUC0-24, Cmax Ratio (day 28/day 35) were evaluated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
Related trials for Onychomycosis
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URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Tschen, MD principal investigator
Academic Dermatology Assoc
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TDT067 and Lamisil in people with Onychomycosis, run by Celtic Pharma Development Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.