Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis

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

A phase 2, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of ORAL albaconazole in subjects with distal subungual onychomycosis. Subjects will take oral study drug for up to 36 weeks and then will be followed for an additional 16 weeks to determine if the study drug was efficacious. Subjects will have routine blood draws and other safety assessments during the study, as well as regular assessments of their toenail fungus

• Drug: Albaconazole 100mg
  Albaconazole for 36 weeks
• Drug: Albaconazole 200mg
  Albaconazole for 36 weeks
• Drug: Albaconazole 400mg
  Albaconazole for 36 weeks
• Drug: Albaconazole 400mg
  Albaconazole for 24 weeks, Placebo for 12 weeks
• Drug: Placebo 400 mg
  Placebo for 36 weeks

• Active Comparator: Albaconazole 100mg
  Albaconazole for 36 weeks
  Intervention: Drug: Albaconazole 100mg
• Active Comparator: Albaconazole 200mg
  Albaconazole for 36 weeks
  Intervention: Drug: Albaconazole 200mg
• Active Comparator: Albaconazole 400mg
  Albaconazole for 36 weeks
  Intervention: Drug: Albaconazole 400mg
• Active Comparator: Albaconazole 400mg 24 weeks, Placebo 12 weeks
  Albaconazole for 24 weeks, Placebo for 12 weeks
  Interventions:

  • Drug: Albaconazole 400mg
  • Drug: Placebo 400 mg
• Placebo Comparator: Placebo 400 mg
  Placebo for 36 weeks
  Intervention: Drug: Placebo 400 mg

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.