Safety and Tolerability Study With Single Ascending Doses of ORM-12741

Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Single Ascending Doses of ORM-12741

The purpose of this study is to evaluate the safety and tolerability of escalating doses of ORM-12741 in healthy volunteers.

Inclusion Criteria:

• Good general health ascertained by detailed medical history and physical examinations
• Males between 18 and 45 years
• Body mass index (BMI) between 18-30 kg/m2
• Weight 55-90 kg

Exclusion Criteria:

• Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
• Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
• Susceptibility to severe allergic reactions
• Regular consumption of more than 14 units of alcohol per week
• Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
• Inability to refrain from using nicotine-containing products during the stay in the study centre
• Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
• Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
• Abnormal finding in ECG, vital signs, laboratory tests or physical examination
• Participation in a drug study within 3 months prior to the start of this study