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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01710670 |
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Date of registration:
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17/10/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects
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Scientific title:
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A Double-blind, Randomized, Placebo-controlled, Three-way Crossover Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects. |
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Date of first enrolment:
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September 2012 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01710670 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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UCB Clinical Trial Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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+1 877 822 9493 (UCB) |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy Volunteers
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Intervention(s)
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Drug: Brivaracetam
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Other: Brivaracetam Placebo
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Other: Ethanol Placebo
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Other: Ethanol
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Primary Outcome(s)
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Visual Analog Scale for alcohol intoxication From 60 minutes Pre-Dose up to 10 hours Post-Dose
[Time Frame: From 60 minutes Pre-Dose up to 10 hours Post-Dose]
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Smooth pursuit eye movements from 60 minutes Pre-Dose up to 10 hours Post-Dose
[Time Frame: From 60 minutes Pre-Dose up to 10 hours Post-Dose]
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Visual Analog Scales for Calmness From 60 minutes Pre-Dose up to 10 hours Post-Dose
[Time Frame: From 60 minutes Pre-Dose up to 10 hours Post-Dose]
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Visual Verbal Learning Test from 1.5 hours Post-Dose up to 6 hours Post-Dose
[Time Frame: From 1.5 hours Post-Dose up to 6 hours Post-Dose]
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Saccadic Eye Movements from 60 minutes Pre-Dose up to 10 hours Post-Dose
[Time Frame: From 60 minutes Pre-Dose up to 10 hours Post-Dose]
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Adaptive tracking from 60 minutes Pre-Dose up to 10 hours Post-Dose
[Time Frame: From 60 minutes Pre-Dose up to 10 hours Post-Dose]
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Body sway from 60 minutes Pre-Dose up to 10 hours Post-Dose
[Time Frame: From 60 minutes Pre-Dose up to 10 hours Post-Dose]
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Visual Analog Scales for Alertness From 60 minutes Pre-Dose up to 10 hours Post-Dose
[Time Frame: From 60 minutes Pre-Dose up to 10 hours Post-Dose]
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Visual Analog Scales for Mood From 60 minutes Pre-Dose up to 10 hours Post-Dose
[Time Frame: From 60 minutes Pre-Dose up to 10 hours Post-Dose]
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Secondary Outcome(s)
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The area under the plasma concentration-time curve from zero to infinity (AUC)
[Time Frame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose]
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The terminal disposition rate constant (?z) with the respective terminal half-life (t1/2)
[Time Frame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose]
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Serum Ethanol concentrations
[Time Frame: From - 30 minutes Pre-Dose to 10 hours Post-Dose]
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The maximum plasma concentration (Cmax)
[Time Frame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose]
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Total Ethanol Dose analyzed by a model independent parameter estimate
[Time Frame: From - 30 minutes Pre-Dose to 10 hours Post-Dose]
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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)]
[Time Frame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose]
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Breath Ethanol concentrations
[Time Frame: From - 30 minutes Pre-Dose to 10 hours Post-Dose]
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The time to reach the maximum plasma concentration (tmax)
[Time Frame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose]
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Secondary ID(s)
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2012-002591-14
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EP0041
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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