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

V

Viamet

Status and phase

Completed
Phase 2

Conditions

Candidiasis, Vulvovaginal

Treatments

Drug: Fluconazole
Drug: VT-1161

Study type

Interventional

Funder types

Industry

Identifiers

NCT01891331
VMT-VT-1161-CL-004

Details and patient eligibility

About

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).

Enrollment

55 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

55 participants in 4 patient groups

VT-1161 300mg QD
Experimental group
Treatment:
Drug: VT-1161
VT-1161 600mg QD
Experimental group
Treatment:
Drug: VT-1161
VT-1161 600mg BID
Experimental group
Treatment:
Drug: VT-1161
Fluconazole 150mg
Active Comparator group
Treatment:
Drug: Fluconazole

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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