Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002591-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects of Ethanol
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethanol + Brivaracetam | Experimental | Treatment A: Ethanol + Brivaracetam |
|
| Ethanol Placebo + Brivaracetam | Experimental | Treatment B: Ethanol Placebo + Brivaracetam |
|
| Ethanol + Brivaracetam Placebo | Experimental | Treatment C: Ethanol + Brivaracetam Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the plasma concentration-time curve from zero to infinity (AUC) | Blood samples will be taken - 5 minutes Pre-Dose, 15, 30, and 60 minutes Post-Dose and then 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours Post-Dose. | 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)] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden | Netherlands |
Not provided
| ID | Term |
|---|---|
| C482793 | brivaracetam |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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 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. |
|
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 |
Blood samples will be taken - 5 minutes Pre-Dose, 15, 30, and 60 minutes Post-Dose and then 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours Post-Dose. |
| From Pre-Dose (- 5 minutes) to 36 hours Post-Dose |
| The maximum plasma concentration (Cmax) | Blood samples will be taken - 5 minutes Pre-Dose, 15, 30, and 60 minutes Post-Dose and then 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours Post-Dose. | From Pre-Dose (- 5 minutes) to 36 hours Post-Dose |
| The time to reach the maximum plasma concentration (tmax) | Blood samples will be taken - 5 minutes Pre-Dose, 15, 30, and 60 minutes Post-Dose and then 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours Post-Dose. | From Pre-Dose (- 5 minutes) to 36 hours Post-Dose |
| The terminal disposition rate constant (λz) with the respective terminal half-life (t1/2) | Blood samples will be taken - 5 minutes Pre-Dose, 15, 30, and 60 minutes Post-Dose and then 2, 3, 4, 5, 6, 8, 10, 12, 24 and 36 hours Post-Dose. | From Pre-Dose (- 5 minutes) to 36 hours Post-Dose |
| Serum Ethanol concentrations | Blood samples for Ethanol concentrations will be taken - 30 minutes, - 15 and - 5 minutes Pre-Dose, then 15, 30 and 60 minutes Post-Dose and then 2, 3, 4, 5, 6, 8, and 10 hours Post-Dose. | From - 30 minutes Pre-Dose to 10 hours Post-Dose |
| Breath Ethanol concentrations | Blood samples for Ethanol concentrations will be taken - 30 minutes, - 15 and - 5 minutes Pre-Dose, then 15, 30 and 60 minutes Post-Dose and then 2, 3, 4, 5, 6, 8, and 10 hours Post-Dose. | From - 30 minutes Pre-Dose to 10 hours Post-Dose |
| Total Ethanol Dose analyzed by a model independent parameter estimate | Blood samples for Ethanol concentrations will be taken - 30 minutes, - 15 and - 5 minutes Pre-Dose, then 15, 30 and 60 minutes Post-Dose and then 2, 3, 4, 5, 6, 8, and 10 hours Post-Dose. | From - 30 minutes Pre-Dose to 10 hours Post-Dose |