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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: UCB Pharma SA
• Treatments: Brivaracetam; Ethanol

Criteria

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