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

Viamet

Status and phase: Completed; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: VT-1161; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01891305

VMT-VT-1161-CL-003

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

50 participants in 4 patient groups, including a placebo group

VT-1161 200/50mg

Experimental group

Treatment:

Drug: VT-1161

VT-1161 600/150mg

Experimental group

Treatment:

Drug: VT-1161

VT-1161 1200/300mg

Experimental group

Treatment:

Drug: VT-1161

Matching placebo

Placebo Comparator group

Treatment:

Drug: placebo