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

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

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.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: placebo; Drug: VT-1161

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Univ Alabama at Birmingham
  • Florida
    • Miami, Florida, United States, 33136
      • Florida Academic Dermatology Center
    • Miramar, Florida, United States, 33027
      • FXM Research
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology & Research Center
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc.
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Pariser Dermatology Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Viamet

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: July 2, 2013
• First Posted (Estimate): July 3, 2013

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 5, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis
• Other Study ID Numbers: VMT-VT-1161-CL-003