A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 7
- 主要终点
- Percentage of Subjects With Therapeutic Cure at 28 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 acute vulvovaginal candidiasis (also referred to as yeast infection). 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. VT-1161 has been design to be safer and more active against the fungal species typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Females ≥18 and <65 years
- •Clinical diagnosis of symptomatic acute VVC
- •Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation).
- •At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)
- •A minimum composite vulvovaginal signs and symptoms score of ≥6
- •must be be able to swallow capsules
排除标准
- •Evidence of major organ system disease
- •History of cervical cancer
- •History of diabetes mellitus
- •Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any reason
- •Recent use of drugs to treat vaginal infections
- •Recent use of immunosuppressive therapies
研究组 & 干预措施
VT-1161 300mg QD
干预措施: VT-1161 (Drug)
VT-1161 600mg QD
干预措施: VT-1161 (Drug)
VT-1161 600mg BID
干预措施: VT-1161 (Drug)
Fluconazole 150mg
干预措施: Fluconazole (Drug)
结局指标
主要结局
Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population
时间窗: 4 weeks
For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following: 1. complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis; 2. any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis; 3. no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.
次要结局
未报告次要终点