PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

Objective:

• To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
• To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects

Inclusion Criteria:

• males of females
• any ethnic origin
• Age 18-55 years
• BMI 18.0 - 33.0 kg/m2
• generally in good health
• signed informed consent

Exclusion Criteria:

• males or females not willing to use appropriate contraception
• recent blood donation
• recent blood received
• high consumption of alcohol
• high consumption of tobacco
• subjects who have engaged in heavy exercise last two weeks
• prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety
• other medication know to alter drug absorption or elimination
• abnormal heart rate or blood pressure or 12-lead ECG
• significant history of drug allergy, or hypersensitivity to treatment ingredients
• ocular disorder requiring topical ocular therapy, or recent allergic eye disease
• other significant medical history or physical findings