This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.

Inclusion Criteria:

• BMI : 18-30 kg/m2 (Body Mass Index [BMI] [kg/m2] = Body weight [kg] Height2 [m2])
• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge
• Medical history without major pathology

Exclusion Criteria:

• Evidence of clinically relevant pathology
• Mental handicap
• History of relevant drug and/or food allergies
• Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center
• Smoking within 60 days prior to drug administration and through the follow-up visit
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products)