Clinical trial NCT01710670: A Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects
Official title: A Double-blind, Randomized, Placebo-controlled, Three-way Crossover Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Brivaracetam
Ethanol
Pharmacodynamics
Pharmacokinetic
Interaction
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-10-19
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


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

Primary outcomes:
measure: Saccadic Eye Movements from 60 minutes Pre-Dose up to 10 hours Post-Dose
timeFrame: From 60 minutes Pre-Dose up to 10 hours Post-Dose
measure: Smooth pursuit eye movements from 60 minutes Pre-Dose up to 10 hours Post-Dose
timeFrame: From 60 minutes Pre-Dose up to 10 hours Post-Dose
measure: Adaptive tracking from 60 minutes Pre-Dose up to 10 hours Post-Dose
timeFrame: From 60 minutes Pre-Dose up to 10 hours Post-Dose
measure: Body sway from 60 minutes Pre-Dose up to 10 hours Post-Dose
timeFrame: From 60 minutes Pre-Dose up to 10 hours Post-Dose
measure: Visual Analog Scales for Mood From 60 minutes Pre-Dose up to 10 hours Post-Dose
timeFrame: From 60 minutes Pre-Dose up to 10 hours Post-Dose
measure: Visual Analog Scale for alcohol intoxication From 60 minutes Pre-Dose up to 10 hours Post-Dose
timeFrame: From 60 minutes Pre-Dose up to 10 hours Post-Dose
measure: Visual Verbal Learning Test from 1.5 hours Post-Dose up to 6 hours Post-Dose
timeFrame: From 1.5 hours Post-Dose up to 6 hours Post-Dose
measure: Visual Analog Scales for Alertness From 60 minutes Pre-Dose up to 10 hours Post-Dose
timeFrame: From 60 minutes Pre-Dose up to 10 hours Post-Dose
measure: Visual Analog Scales for Calmness From 60 minutes Pre-Dose up to 10 hours Post-Dose
timeFrame: From 60 minutes Pre-Dose up to 10 hours Post-Dose
Secondary outcomes:
measure: The area under the plasma concentration-time curve from zero to infinity (AUC)
timeFrame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose
measure: 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)]
timeFrame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose
measure: The maximum plasma concentration (Cmax)
timeFrame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose
measure: The time to reach the maximum plasma concentration (tmax)
timeFrame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose
measure: The terminal disposition rate constant (λz) with the respective terminal half-life (t1/2)
timeFrame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose
measure: Serum Ethanol concentrations
timeFrame: From - 30 minutes Pre-Dose to 10 hours Post-Dose
measure: Breath Ethanol concentrations
timeFrame: From - 30 minutes Pre-Dose to 10 hours Post-Dose
measure: Total Ethanol Dose analyzed by a model independent parameter estimate
timeFrame: From - 30 minutes Pre-Dose to 10 hours Post-Dose
Other outcomes:
Locations:
city: Leiden
country: Netherlands
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: