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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
VT-1161 200/50mg
干预措施: VT-1161 (Drug)
VT-1161 600/150mg
干预措施: VT-1161 (Drug)
VT-1161 1200/300mg
干预措施: VT-1161 (Drug)
Matching placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
时间窗: 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.
次要结局
未报告次要终点