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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Brivaracetam Placebo; Other: Ethanol Placebo; Other: Ethanol; Drug: Brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01710670

2012-002591-14 (EudraCT Number)

EP0041

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

18 participants in 3 patient groups

Ethanol + Brivaracetam

Experimental group

Description:

Treatment A: Ethanol + Brivaracetam

Treatment:

Drug: Brivaracetam

Other: Ethanol

Ethanol Placebo + Brivaracetam

Experimental group

Description:

Treatment B: Ethanol Placebo + Brivaracetam

Treatment:

Other: Ethanol Placebo

Drug: Brivaracetam

Ethanol + Brivaracetam Placebo

Experimental group

Description:

Treatment C: Ethanol + Brivaracetam Placebo

Treatment:

Other: Brivaracetam Placebo

Other: Ethanol