Phase 2 N=55 Randomized Triple-blind Treatment

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

Candidiasis, Vulvovaginal

Bottom Line

View on ClinicalTrials.gov: NCT01891331 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2018

Primary outcome: Primary: Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population — 9; 9; 11; 10 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: VT-1161 (Drug); Fluconazole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Viamet
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population	9; 9; 11; 10	—

Summary

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01891331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.