A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Moderate to Severe Interdigital Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: VT-1161
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VT-1161 200/50mg<br> | Drug: VT-1161<br> <br> |
| Experimental: VT-1161 600/150mg<br> | Drug: VT-1161<br> <br> |
| Experimental: VT-1161 1200/300mg<br> | Drug: VT-1161<br> <br> |
| Placebo Comparator: Matching placebo<br> | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks |