A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)

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).

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Key information

Conditions

Candidiasis, Vulvovaginal Bacterial Infections and Mycoses Candidiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Altus Research, Lake Worth, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Exclusion criteria

Evidence of major organ system disease
History of cervical cancer
History of diabetes mellitus
Pregnant
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

Treatment and study plan

VT-1161

Drug

Fluconazole

Drug

Primary outcomes

Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population

Time frame: 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:
- complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis;
- any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis;
- no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.

Sponsors and collaborators

Lead sponsor

Viamet

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jul 3, 2013
Registry last updated: Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed