A Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects

A Double-blind, Randomized, Placebo-controlled, Three-way Crossover Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects.

To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects of Ethanol

Inclusion Criteria:

• Healthy male volunteers with the age between 18 and 55 years old

Exclusion Criteria:

• Subject has participated or is participating in any other clinical studies of investigational drug or another investigational medical product within the last 3 months or has participated in 4 or more Investigational Medicinal Product (IMP) studies within 1 year prior to screening
• Subject is not healthy (eg, taking any drug treatments except use of Paracetamol, excessive amount of alcohol, cigarettes, caffeine consumption, having a positive drug / alcohol abuse, having abnormal safety parameters)
• Subject has not been vaccinated for hepatitis
• Subjects has consumed any grapefruits, grapefruits juice, grapefruit-containing products or star fruit within 14 days prior to dosing or not able to refrain from these products during the study
• Subject has Ethanol intolerance
• Subject has a known hypersensitivity to any components of the Investigational Medicinal Product (IMP)
• Subject has made a blood donation or a comparable blood loss (500 ml) within the last 3 months prior to screening
• subject is an employee of the investigator or study center or subject is a first line family member of an employee working in the respective study center or of the investigator