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



Status:Completed
Conditions:Podiatry
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 70
Updated:12/16/2017
Start Date:February 17, 2015
End Date:October 18, 2016

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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

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.


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.
We found this trial at
33
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Columbus, Ohio 43212
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
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8042 Wurzbach Road
San Antonio, Texas 78229
210-949-0807
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Akron, Ohio 44311
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Albuquerque, New Mexico 87106
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Austin, Texas 78759
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Baltimore, Maryland 21214
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Baltimore, MD
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Birmingham, AL
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Boise, Idaho 83704
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Cincinnati, Ohio 45249
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College Station, Texas
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Dallas, Texas 75243
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Forest Hills, New York 11375
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Greer, South Carolina
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Knoxville, Tennessee 37922
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Miami, FL
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Mount Pleasant, South Carolina 29464
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Nashville, Tennessee 37215
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Newburgh, Indiana 37215
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Norfolk, Virginia 23507
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Oceanside, California 92056
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Omaha, Nebraska 68144
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Philadelphia, Pennsylvania 19103
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Pinellas Park, Florida 33781
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Portland, Oregon 97210
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Portland, Oregon 97223
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Rochester, New York 14623
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San Diego, California 92123
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San Francisco, California 94115
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Santa Rosa, California 95405
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Tucson, Arizona 85710
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York, Pennsylvania 17403
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