Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onyc… (NCT05110638) | Clinical Trial Compass
UnknownPhase 1
Safety and Tolerability Study of SKX-16 in Subjects With Moderate to Severe Distal Subungual Onychomycosis
United States20 participantsStarted 2021-09-13
Plain-language summary
This study is being conducted to determine the pharmacokinetics, systemic exposure, safety and tolerability after daily topical application of SKX-16 (Luliconazole 10% Solution) for duration of 29 days in a maximal use setting in adults with moderate to severe distal subungual onychomycosis of the toenails.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Subjects demonstrate ability and willingness to sign a written informed consent.
✓. Subjects of either gender, any race and between the ages of 18 and 65 inclusive.
✓. Subjects must have ten toes.
✓. Subjects with a clinical diagnosis of distal subungual onychomycosis involving both great toenails and ≥ 50% of at least one of the great toenails, as determined by visual inspection after the nail is trimmed.
✓. In addition to both great toenails, subjects must have at least four additional toenails with clinical diagnosis of distal subungual onychomycosis.
✓. Subjects must have a mycological diagnosis of distal subungual onychomycosis: fungal hyphae on KOH wet mount and positive fungal culture for dermatophyte (microbial infection with fungus belonging to the genus Trichophyton, Microsporum, Epidermophyton) from at least one great toenail.
✓. Subjects must have normal renal function as measured by serum creatinine \< ULN.
✓. Subjects must have normal hepatic function as measured by aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and total bilirubin \< ULN.
Exclusion criteria
✕. Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution.
✕. Subjects with an abnormal ECG morphology and/or a QTcF interval \> 450 ms for males and \>470 ms for females.
What they're measuring
1
PK parameters for the systemic absorption of luliconazole - AUC0-24h
Timeframe: 36 days
2
PK parameters for the systemic absorption of luliconazole - AUC0-∞
Timeframe: 36 days
3
PK parameters for the systemic absorption of luliconazole - Cmax
Timeframe: 36 days
4
PK parameters for the systemic absorption of luliconazole - Tmax
Timeframe: 36 days
5
PK parameters for the systemic absorption of luliconazole - t1/2
Timeframe: 36 days
6
PK parameters for the systemic absorption of luliconazole - kel
Timeframe: 36 days
7
Safety Assessment - Local Application Site Tolerability Assessment (LASTA)
. Subjects with any history of cardiac disease or cardiac rhythm abnormalities.
✕. Subjects with symptomatic tinea pedis at baseline.
✕. Subjects unwilling to refrain from the use of nail cosmetics including nail lacquers from the Screening visit until the end of the study.
✕. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
✕. Concomitant use of any drugs that are CYP3A and CYP2C19 substrates with QT interval prolongation potential.
✕. Subjects who have not undergone the specified washout period(s) prior to Baseline visit (Day 1) for the following topical preparations, or subjects requiring the concurrent use of any of the following topical medications: Topical antifungal applied to the feet, drugs that contain luliconazole, anti-inflammatories, corticosteroids or topical immunomodulators.