Overview

This trial is active, not recruiting.

Condition onychomycosis
Treatments vt-1161, placebo
Phase phase 2
Sponsor Viamet
Start date December 2014
End date July 2016
Trial size 200 participants
Trial identifier NCT02267356, VMT-VT-1161-CL-005

Summary

VT-1161 is a novel, oral inhibitor of fungal lanosterol demethylase (CYP51). In vitro and in vivo pharmacology studies have demonstrated that VT-1161 is highly active against dermatophytes that cause onychomycosis . VT-1161 is highly selective for fungal CYP51, and data suggests that it may avoid the side-effect profile that limits the use of commonly prescribed antifungal agents for the treatment of onychomycosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Low dose 12-week: Loading doses of 300 mg once daily for 2 weeks, then 300 mg once weekly for 10 weeks, followed by placebo for 12 weeks
vt-1161
(Experimental)
High dose 12-week: Loading doses of 600 mg once daily for 2 weeks, then 600 mg once weekly for 10 weeks, followed by placebo for 12 weeks
vt-1161
(Experimental)
Low dose 24-week: Loading doses of 300 mg once daily for 2 weeks, then 300 mg once weekly for 22 weeks
vt-1161
(Experimental)
High dose 24-week: Loading doses of 600 mg once daily for 2 weeks, then 600 mg once weekly for 22 weeks
vt-1161
(Placebo Comparator)
Placebo tablets corresponding to the VT-1161 dosed for 24 weeks
placebo

Primary Outcomes

Measure
To evaluate the efficacy of 4 dosing regimens of VT-1161 compared to placebo in the treatment of subjects with distal lateral subungual onychomycosis (DLSO) of the toenail
time frame: 48 Weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Key Inclusion Criteria: Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail. Positive culture for dermatophytes and positive KOH. Nail ≤ 3 mm thick at the distal end. At least ≥ 2 mm of the proximal end of the great toenail must be free of infection. Subjects must be able to swallow tablets. Women of childbearing potential and males must use acceptable birth control methods throughout the study. Key Exclusion Criteria: Presence of subungual hematoma or melanonychia. Presence of dermatophytoma/nail streaks and severe onychorrhexis. Significant dystrophy or anatomic abnormalities of the great toenail. Presence of any other infections of the foot. Evidence of clinically significant major organ disease. Poorly controlled diabetes mellitus. Onychomycosis involving more than 8 toe nails. Recent use of systemic antifungal therapy. Recent of any topical antifungal nail therapy. Recent use of systemic corticosteroid therapy. Recent use of immunosuppressive medication. History of prolonged QT intervals. Known human immunodeficiency virus (HIV) infection. Known significant renal or hepatic impairment. Known history of intolerance or hypersensitivity to azole antifungal drugs.

Additional Information

Official title A Phase 2, 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 Distal Lateral Subungual Onychomycosis of the Toenail
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Viamet.