Tinea Pedis
Conditions
Brief summary
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.
Interventions
DRUGVT-1161
DRUGplacebo
Sponsors
Viamet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Healthy male and non-pregnant female patients ≥18 years and \<65 years * Clinical diagnosis of tinea pedis * Positive baseline KOH * Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity) * Patients must be able to swallow capsules intact * Use acceptable birth control methods Key
Exclusion criteria
* Major organ system disease or clinical infection * Poorly controlled diabetes mellitus * Pregnant or lactating * Confluent, diffuse moccasin-type tinea pedis * Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail * Recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot * Recent use of systemic corticosteroids or antifungal therapy * Known(HIV)infection * Known significant hepatic, or hematologic impairment .Requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population | 6 weeks | For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VT-1161 200/50mg | 12 |
| VT-1161 600/150mg | 12 |
| VT-1161 1200/300mg | 14 |
| Matching Placebo | 12 |
| Total | 50 |
Baseline characteristics
| Characteristic | VT-1161 200/50mg | VT-1161 600/150mg | VT-1161 1200/300mg | Matching Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 12.84 | 40.6 years STANDARD_DEVIATION 11.71 | 34.05 years STANDARD_DEVIATION 12.02 | 35.2 years STANDARD_DEVIATION 10.27 | 38.9 years STANDARD_DEVIATION 12.32 |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 3 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 11 Participants | 7 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 12 | 3 / 12 | 5 / 14 | 5 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 14 | 0 / 12 |
Outcome results
Primary
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VT-1161 200/50mg | Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population | 2 Participants |
| VT-1161 600/150mg | Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population | 1 Participants |
| VT-1161 1200/300mg | Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population | 3 Participants |
| Matching Placebo | Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population | 0 Participants |