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A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail

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ClinicalTrials.gov Identifier: NCT02267356
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Viamet

Brief 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.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: VT-1161 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : February 17, 2015
Actual Primary Completion Date : October 18, 2016
Actual Study Completion Date : October 18, 2016

Arm Intervention/treatment
Experimental: Arm 1 Active
Low dose 12-week: Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 10 weeks, followed by placebo for 12 weeks
Drug: VT-1161
Experimental: Active Arm 2
High dose 12-week: Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 10 weeks, followed by placebo for 12 weeks
Drug: VT-1161
Experimental: Active Arm 3
Low dose 24-week: Loading doses of VT-1161 300mg once daily for 2 weeks, then 300mg once weekly for 22 weeks
Drug: VT-1161
Experimental: Active Arm 4
High dose 24-week: Loading doses of VT-1161 600mg once daily for 2 weeks, then 600mg once weekly for 22 weeks
Drug: VT-1161
Placebo Comparator: Control Arm
Placebo tablets corresponding to VT-1161 dosed for 24 weeks
Drug: Placebo



Primary Outcome Measures :
  1. 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 ]
    The primary efficacy variable will be measured at Week 48 and will be the proportion of subjects with complete cure, defined as both complete clinical cure (0% nail involvement) and mycological cure (defined as both negative KOH and negative dermatophyte culture).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267356


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Sponsors and Collaborators
Viamet

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Responsible Party: Viamet
ClinicalTrials.gov Identifier: NCT02267356     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-005
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases