A Study of the Systemic Absorption of MOB015B

Exclusion Criteria

• •1. Female subjects who are pregnant, nursing/breastfeeding, or plan to become pregnant within the study period.
• •2. Subjects with chronic or active liver disease, renal impairment, cutaneous or systematic lupus erythematosus, or any other disease or medical condition that in the opinion of the investigator would interfere with the study or place the subject at undue risk.
• •3. Subject with hypersensitivity to terbinafine or the vehicle excipients.
• •4. Subjects who have been treated with systematic formulations of terbinafine in the 12 months prior to the Day 1 visit.
• •5. Subjects who have been treated with topical formulations of terbinafine in the 6 months prior to the day 1 visit.
• •6. Subjects who take or have taken systematic medication that may interfere with the study or place the subject at undue risk in the 30 days before the day 1 visit (e.g., rifampin, cimetidine, phenobarbital, phenytoin, carbamazepine, terfenadine or digoxin).
• •7. Subjects who take or have taken systemic medication in the 30 days before the Day 1 visit that interferes with the terbinafine plasma assay.
• •8. Subjects who have consumed grapefruit products during the 30 days prior to the Day 1 visit.
• •9. Subjects who are not willing to refrain from caffeinated beverage consumption on Day 1 and 28.
• •10. Subjects with a current history of consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to Day 1 visit (one drink is equal to one unit of alcohol, one glass of wine, half pint of beer or one ounce of spirits).
• •11. Subjects with an ongoing or recent history of treatment for substance abuse.
• •12. Subjects who have participated in a study of an investigational drug 60 days prior to the Day 1 visit.
• •13. Subjects with a history of multiple syncopal episodes.
• •14. Subjects with positive tests for drugs or alcohol at Day 1 visit.
• •15. Subjects who are unable to comply with study requirements.
• •16. Subjects who are not willing to abstain from all toenail treatments such as toenail polish, pedicures and/or foot soaks (including nail clipping or debridement), for 3 days prior to Day 1 visit and during the study.
• •17. Donation of blood (one unit or 350 mL) within 90 days prior to Day 1 visit.
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