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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

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.

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Detailed Description

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Conditions

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Tinea Pedis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VT-1161 200/50mg

Group Type EXPERIMENTAL

VT-1161

Intervention Type DRUG

VT-1161 600/150mg

Group Type EXPERIMENTAL

VT-1161

Intervention Type DRUG

VT-1161 1200/300mg

Group Type EXPERIMENTAL

VT-1161

Intervention Type DRUG

Matching placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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VT-1161

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No