Healthy VolunteersPhase 1NCT01710670

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

A Phase 1 study testing Brivaracetam and Ethanol in people with Healthy Volunteers, run by UCB Pharma SA at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects of Ethanol Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Brivaracetam and Ethanol
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteNetherlands
Study dates: Sep 2012to Nov 2012
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Study site
Leiden

Other trials in Netherlands

About this study

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.

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

Conditions: Healthy Volunteers
Being tested: Brivaracetam, Ethanol, Brivaracetam Placebo, Ethanol Placebo
Keywords: Brivaracetam, Ethanol, Pharmacodynamics, Pharmacokinetic, Interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BrivaracetamDrug
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.
EthanolOther
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 PlaceboOther
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 PlaceboOther
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.

Study groups in NCT01710670
Study group	Role	What they receive
Ethanol + Brivaracetam	Experimental	Treatment A: Ethanol + Brivaracetam Receives: Drug: Brivaracetam; Other: Ethanol
Ethanol Placebo + Brivaracetam	Experimental	Treatment B: Ethanol Placebo + Brivaracetam Receives: Drug: Brivaracetam; Other: Ethanol Placebo
Ethanol + Brivaracetam Placebo	Experimental	Treatment C: Ethanol + Brivaracetam Placebo Receives: Other: Ethanol; Other: Brivaracetam Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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.
Measured: 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)]
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From - 30 minutes Pre-Dose to 10 hours Post-Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2012Nov 2012

First posted19 Oct 2012 (estimated)
Study startSep 2012
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01710670
Sponsor's protocol ID: EP0041
Other IDs: 2012-002591-14
Status last verified: Dec 2012
First submitted: 17 Oct 2012
Last updated: 11 Oct 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01710670
Acronym / sponsor ID: EP0041
Conditions: Healthy Volunteers
Keywords: Brivaracetam, Ethanol, Pharmacodynamics, Pharmacokinetic, Interaction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: UCB Pharma SAIndustry (pharma, biotech, devices)
Study start: Sep 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 19 Oct 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Ethanol + Brivaracetam	Experimental	Drug: Brivaracetam, Other: EthanolTreatment A: Ethanol + Brivaracetam
Ethanol Placebo + Brivaracetam	Experimental	Drug: Brivaracetam, Other: Ethanol PlaceboTreatment B: Ethanol Placebo + Brivaracetam
Ethanol + Brivaracetam Placebo	Experimental	Other: Ethanol, Other: Brivaracetam PlaceboTreatment C: Ethanol + Brivaracetam Placebo

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BrivaracetamStrength: 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.	Drug	Ethanol + Brivaracetam, Ethanol Placebo + Brivaracetam
EthanolForm: 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.	Other	Ethanol + Brivaracetam, Ethanol + Brivaracetam Placebo
Brivaracetam PlaceboIn 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.	Other	Ethanol + Brivaracetam Placebo
Ethanol PlaceboIn 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.	Other	Ethanol Placebo + Brivaracetam

Primary outcome

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
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.
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
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.
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
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.
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
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)
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
Visual Analog Scales according to Bond and Lader
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
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.
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
Immediate recall, immediate recognition, delayed recall, and delayed recognition to evaluate memory
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
Visual Analog Scales according to Bond and Lader
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
Visual Analog Scales according to Bond and Lader

8 secondary outcomes

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
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
The maximum plasma concentration (Cmax)
Time frame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose
The time to reach the maximum plasma concentration (tmax)
Time frame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose
The terminal disposition rate constant (λz) with the respective terminal half-life (t1/2)
Time frame: From Pre-Dose (- 5 minutes) to 36 hours Post-Dose
Serum Ethanol concentrations
Time frame: From - 30 minutes Pre-Dose to 10 hours Post-Dose
Breath Ethanol concentrations
Time frame: From - 30 minutes Pre-Dose to 10 hours Post-Dose
Total Ethanol Dose analyzed by a model independent parameter estimate
Time frame: From - 30 minutes Pre-Dose to 10 hours Post-Dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.

Related trials for Healthy Volunteers

Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brivaracetam and Ethanol in people with Healthy Volunteers, run by UCB Pharma SA at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01710670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.