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

NCT ID: NCT01710670

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2012-11-30

Brief Summary

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

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Ethanol + Brivaracetam

Treatment A: Ethanol + Brivaracetam

Group Type: EXPERIMENTAL

Brivaracetam

Intervention Type: DRUG

Strength: 200 mg (4 x 50 mg)

Form: oral tablet

Frequency: single dose

Description: All subjects will receive a single oral dose of Brivaracetam (BRV) 200 mg, given as 50 mg tablets times 4 followed by an adequate volume of water (approximately 200 ml) in 2 of the 3 crossover periods. This dose will be administered 30 minutes after the initiation of the Ethanol / Ethanol Placebo infusion on Day 1.

Ethanol

Intervention Type: OTHER

Form: intravenous infusion

Frequency: continuous infusion

Description: The ethanol infusion rate is initially based on weight, height, age, and sex. Subsequently, the infusion rate will be adjusted based on Breath Ethanol Measurements to maintain Breath Ethanol Levels (and by extension, blood ethanol levels) of 0.6 g / L.

Ethanol Placebo + Brivaracetam

Treatment B: Ethanol Placebo + Brivaracetam

Group Type: EXPERIMENTAL

Brivaracetam

Intervention Type: DRUG

Strength: 200 mg (4 x 50 mg)

Form: oral tablet

Frequency: single dose

Description: All subjects will receive a single oral dose of Brivaracetam (BRV) 200 mg, given as 50 mg tablets times 4 followed by an adequate volume of water (approximately 200 ml) in 2 of the 3 crossover periods. This dose will be administered 30 minutes after the initiation of the Ethanol / Ethanol Placebo infusion on Day 1.

Ethanol Placebo

Intervention Type: OTHER

In 1 crossover period subjects will receive Ethanol Placebo (5% glucose). On Day 1, the continuous infusion of Ethanol Placebo will begin with a 30 minute Loading Phase prior to administration of Brivaracetam (BRV) / BRV Placebo and will continue until 5 hours after administration of BRV/BRV Placebo. During the first 10 minutes, the infusion will be accompanied by an infusion of 5% Glucose via the same line in order to mask the sensation at the beginning of the Ethanol infusion.

Ethanol + Brivaracetam Placebo

Treatment C: Ethanol + Brivaracetam Placebo

Group Type: EXPERIMENTAL

Ethanol

Intervention Type: OTHER

Form: intravenous infusion

Frequency: continuous infusion

Description: The ethanol infusion rate is initially based on weight, height, age, and sex. Subsequently, the infusion rate will be adjusted based on Breath Ethanol Measurements to maintain Breath Ethanol Levels (and by extension, blood ethanol levels) of 0.6 g / L.

Brivaracetam Placebo

Intervention Type: OTHER

In 1 of the 3 crossover periods, all subjects will receive 4 Placebo tablets to match the 50 mg Brivaracetam (BRV) tablets. The Placebo tablet will contain the same excipients as the BRV tablets but without BRV.

Interventions

Brivaracetam

Strength: 200 mg (4 x 50 mg)

Form: oral tablet

Frequency: single dose

Description: All subjects will receive a single oral dose of Brivaracetam (BRV) 200 mg, given as 50 mg tablets times 4 followed by an adequate volume of water (approximately 200 ml) in 2 of the 3 crossover periods. This dose will be administered 30 minutes after the initiation of the Ethanol / Ethanol Placebo infusion on Day 1.

Intervention Type: DRUG

Ethanol

Form: intravenous infusion

Frequency: continuous infusion

Description: The ethanol infusion rate is initially based on weight, height, age, and sex. Subsequently, the infusion rate will be adjusted based on Breath Ethanol Measurements to maintain Breath Ethanol Levels (and by extension, blood ethanol levels) of 0.6 g / L.

Intervention Type: OTHER

Brivaracetam Placebo

In 1 of the 3 crossover periods, all subjects will receive 4 Placebo tablets to match the 50 mg Brivaracetam (BRV) tablets. The Placebo tablet will contain the same excipients as the BRV tablets but without BRV.

Intervention Type: OTHER

Ethanol Placebo

In 1 crossover period subjects will receive Ethanol Placebo (5% glucose). On Day 1, the continuous infusion of Ethanol Placebo will begin with a 30 minute Loading Phase prior to administration of Brivaracetam (BRV) / BRV Placebo and will continue until 5 hours after administration of BRV/BRV Placebo. During the first 10 minutes, the infusion will be accompanied by an infusion of 5% Glucose via the same line in order to mask the sensation at the beginning of the Ethanol infusion.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

Leiden, , Netherlands

Countries

Netherlands

Other Identifiers

2012-002591-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EP0041

Identifier Type: -

Identifier Source: org_study_id