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

NCT01710670 | Completed Phase 1

• 2 other identifiers: EP00412012-002591-14
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Brivaracetam; Ethanol; Pharmacodynamics; Pharmacokinetic; Interaction

Outcome Measures

Primary Outcomes (9)

• Saccadic Eye Movements from 60 minutes Pre-Dose up to 10 hours Post-Dose

  Average values of Latency (reaction time), Saccadic Peak Velocity, and Inaccuracy (difference between stimulus angle and corresponding saccade in percentages) will be calculated for all artifact-free saccades.

  From 60 minutes Pre-Dose up to 10 hours Post-Dose

• Smooth pursuit eye movements from 60 minutes Pre-Dose up to 10 hours Post-Dose

  The time during which the eyes are in smooth pursuit of the target will be calculated for each frequency and expressed as a percentage of stimulus duration. The average percentage of smooth pursuit for all stimulus frequencies will be used as a parameter.

  From 60 minutes Pre-Dose up to 10 hours Post-Dose

• Adaptive tracking from 60 minutes Pre-Dose up to 10 hours Post-Dose

  Performance will be scored after a fixed period of 3.5 minutes and reflected visuo motor control and vigilance. The average performance scores will be used in the analysis.

  From 60 minutes Pre-Dose up to 10 hours Post-Dose

• Body sway from 60 minutes Pre-Dose up to 10 hours Post-Dose

  The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. (antero-posterior sway in mm / 2 minutes)

  From 60 minutes Pre-Dose up to 10 hours Post-Dose

• Visual Analog Scales for Mood From 60 minutes Pre-Dose up to 10 hours Post-Dose

  Visual Analog Scales according to Bond and Lader

  From 60 minutes Pre-Dose up to 10 hours Post-Dose

• Visual Analog Scale for alcohol intoxication From 60 minutes Pre-Dose up to 10 hours Post-Dose

  The scale consists of a 10 cm line anchored on the left end by "sober" and on the right end by "drunk." Subjects mark a point on the line that best represents their subjective state corresponding to the condition tested. The result is a distance calculated from the mark on the line.

  From 60 minutes Pre-Dose up to 10 hours Post-Dose

• Visual Verbal Learning Test from 1.5 hours Post-Dose up to 6 hours Post-Dose

  Immediate recall, immediate recognition, delayed recall, and delayed recognition to evaluate memory

  From 1.5 hours Post-Dose up to 6 hours Post-Dose

• Visual Analog Scales for Alertness From 60 minutes Pre-Dose up to 10 hours Post-Dose

  Visual Analog Scales according to Bond and Lader

  From 60 minutes Pre-Dose up to 10 hours Post-Dose

• Visual Analog Scales for Calmness From 60 minutes Pre-Dose up to 10 hours Post-Dose

  Visual Analog Scales according to Bond and Lader

  From 60 minutes Pre-Dose up to 10 hours Post-Dose

Secondary Outcomes (8)

• The area under the plasma concentration-time curve from zero to infinity (AUC)

  From Pre-Dose (- 5 minutes) to 36 hours Post-Dose

• The area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification [AUC(0-t)]

  From Pre-Dose (- 5 minutes) to 36 hours Post-Dose

• The maximum plasma concentration (Cmax)

  From Pre-Dose (- 5 minutes) to 36 hours Post-Dose

• The time to reach the maximum plasma concentration (tmax)

  From Pre-Dose (- 5 minutes) to 36 hours Post-Dose

• The terminal disposition rate constant (λz) with the respective terminal half-life (t1/2)

  From Pre-Dose (- 5 minutes) to 36 hours Post-Dose

Study Arms (3)

Ethanol + Brivaracetam

EXPERIMENTAL

Treatment A: Ethanol + Brivaracetam

Drug: Brivaracetam; Other: Ethanol

Ethanol Placebo + Brivaracetam

EXPERIMENTAL

Treatment B: Ethanol Placebo + Brivaracetam

Drug: Brivaracetam; Other: Ethanol Placebo

Ethanol + Brivaracetam Placebo

EXPERIMENTAL

Treatment C: Ethanol + Brivaracetam Placebo

Other: Ethanol; Other: Brivaracetam Placebo

Interventions

Brivaracetam 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 + Brivaracetam; Ethanol Placebo + Brivaracetam

Ethanol 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 + Brivaracetam; Ethanol + Brivaracetam Placebo

Brivaracetam Placebo 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.

Ethanol + Brivaracetam Placebo

Ethanol Placebo 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 Placebo + Brivaracetam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma SA: lead

Study Sites (1)

Unknown Facility

Leiden, Netherlands

Location

MeSH Terms

Interventions

brivaracetam; Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 19, 2012
• Study Start: September 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 11, 2018

Record last verified: 2012-12

Locations

NL (1)