Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: Albaconazole 100mg; Albaconazole 200mg; Albaconazole 400mg; Albaconazole 400mg; Placebo 400 mg
Intervention description: Albaconazole for 36 weeks; Albaconazole for 36 weeks; Albaconazole for 36 weeks; Albaconazole for 24 weeks, Placebo for 12 weeks; Placebo for 36 weeks
Intervention MeSH terms: Albaconazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 582.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Distal, Subungual onychomycosis; onychomycosis; nail fungus; Toenail fungus

Summary:

      Phase 2 study to examine how the study drug works and its side effects in subjects with
      toenail fungus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject aged 18 to 75 years.

          -  Diagnosis with distal subungual onychomycosis of the toenails that affects at least
             one great toe (target toenail).

          -  Subject is willing to provide signed and dated written voluntary informed consent (and
             any local or national authorization requirements) before any protocol-specific
             procedures are performed.

          -  Subject is able to complete the study, comply with study instructions, and take study
             product orally.

          -  Sexually active non-lactating females of childbearing potential participating in the
             study must agree to use a medically acceptable method of contraception while receiving
             protocol-assigned product and up to the first menses 60 days following the last dose
             of study product.

          -  Women of childbearing potential must have a negative pregnancy test at enrollment.

          -  Subject has screening laboratory parameters and ECG within the normal ranges unless
             considered to be not clinically relevant by the principal investigator.

        Exclusion Criteria:

        Subjects with any of the following conditions or characteristics will be excluded from
        study enrollment (ie, will not receive study product):

          -  Subject has received an investigational drug within 4 weeks of the first dose of study
             product, or who are scheduled to receive an investigational drug other than the study
             product during the study.

          -  Subject has participated in a clinical trial for the systemic treatment of
             onychomycosis of the toenails within 6 months prior to the first dose of study
             product.

          -  Subject is receiving any drugs that are known substrates of the 3A4 isozyme of
             cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant
             medications listed under prohibited medication section.

          -  Subject has a history of known or suspected intolerance to albaconazole or the
             formulation excipients, or to azole antifungal drugs in general.

          -  Subject has previously participated in a clinical study with albaconazole.

          -  Subject is not prepared to give up use of any nail cosmetic products for the duration
             of the study.

          -  Subject has any known immunodeficiency or history of malignancy in the last 4 years,
             excluding nonmelanoma skin cancer.

          -  Subject has any known liver disease or a history of liver toxicity with other drugs.

          -  Subject is currently suffering from any disease or condition, that could include
             abnormal laboratory tests, and/or who are currently using medication which in the
             opinion of the investigator may affect the evaluation of the study product or place
             the subject at undue risk.

          -  Subject has psoriasis, lichen planus, or other abnormalities that could result in a
             clinically abnormal toenail.

          -  Subject has a history of any condition that could possibly affect absorption of drug
             (eg, gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular
             disease or peripheral circulatory impairment, or has had any major illness within 30
             days prior to the screening examination.

          -  Subject has a history of drug, prescription medicine, or alcohol abuse within the past
             2 years.

          -  Female subjects who are pregnant, trying to become pregnant, or lactating.

          -  Employees of Investigator/clinical research organization (CRO) or Stiefel
             Laboratories, Inc., or an immediate family member (partner, offspring, parents,
             siblings or sibling's offspring) of an employee.