Healthy VolunteersPhase 1NCT01796899
Comparison of Brivaracetam Oral Tablet (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam Injection (100 mg) in Healthy Volunteers
A Phase 1 study testing Brivaracetam 10 mg oral tablet, Brivaracetam 50 mg oral tablet and Brivaracetam 75 mg oral tablet in people with Healthy Volunteers, run by UCB Pharma SA at 1 site in Netherlands.
Trial summary
To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Brivaracetam 10 mg oral tablet, Brivaracetam 50 mg oral tablet and Brivaracetam 75 mg oral tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Mar 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy male or female volunteer aged 18-55 years inclusive
- Subject has a Body Mass Index (BMI) of 18.0 - 30.0 kg/m^2 and a weight of at least 50 kg (males) or 45 kg (females)
- Subject has normal vital signs values, Electrocardiograms (ECGs) and clinical laboratory values
- Female subjects should have a negative pregnancy test or be of non-childbearing potential
Who cannot join
- Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
- Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- Subject has an intolerance or allergy against the compound or related drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-center, Open-label, 5-way Crossover, Single-dose Bioavailability/Bioequivalence Comparison of Brivaracetam Oral Tablets (10 mg, 50 mg,75 mg, and 100 mg) and Brivaracetam Intravenous Bolus Injection (100 mg) in Healthy Volunteers
To investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Brivaracetam 10 mg oral tablet, Brivaracetam 50 mg oral tablet, Brivaracetam 75 mg oral tablet, Brivaracetam 100 mg oral tablet, 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)
- Keywords
- Healthy Volunteers, Brivaracetam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brivaracetam 10 mg oral tabletOther
Brivaracetam 50 mg oral tabletOther
Brivaracetam 75 mg oral tabletOther
Brivaracetam 100 mg oral tabletOther
10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)Other
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam 10 mg oral tablet | Other | Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 10 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
* Strength: 10 mg
* Form: Oral tablet
* Frequency: Once daily
* Duration: 1 day Receives: Other: Brivaracetam 10 mg oral tablet |
| Brivaracetam 50 mg oral tablet | Other | Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 50 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
* Strength: 50 mg
* Form: Oral tablet
* Frequency: Once daily
* Duration: 1 day Receives: Other: Brivaracetam 50 mg oral tablet |
| Brivaracetam 75 mg oral tablet | Other | Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 75 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
* Strength: 75 mg
* Form: Oral tablet
* Frequency: Once daily
* Duration: 1 day Receives: Other: Brivaracetam 75 mg oral tablet |
| Brivaracetam 100 mg oral tablet | Other | Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 100 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
* Strength: 100 mg
* Form: Oral tablet
* Frequency: Once daily
* Duration: 1 day Receives: Other: Brivaracetam 100 mg oral tablet |
| 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL) | Other | Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of 10 mL of BRV intravenous bolus injection (10 mg/mL) will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations.
* Strength: 100 mg (10 mg/mL)
* Form: Intravenous bolus injection
* Frequency: Once daily
* Duration: 1 day Receives: Other: 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax)
Measured: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification dose-normalized to the 50 mg reference treatment (AUC[0-t])
Measured: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Area under the plasma concentration-time curve from zero to infinity dose-normalized to the 50 mg reference treatment (AUC)
Measured: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Secondary outcomes (4)
Plasma half-life of Brivaracetam
Measured: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Time to reach the maximum plasma concentration of Brivaracetam (tmax)
Measured: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Apparent oral clearance of Brivaracetam (CL/F)
Measured: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Apparent volume of Brivaracetam distribution at the terminal elimination phase
Measured: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionMar 2013
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796899
- Sponsor's protocol ID
- EP0007
- Other IDs
- 2012-001358-25
- Status last verified
- Apr 2013
- First submitted
- 19 Feb 2013
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-center, Open-label, 5-way Crossover, Single-dose Bioavailability/Bioequivalence Comparison of Brivaracetam Oral Tablets (10 mg, 50 mg,75 mg, and 100 mg) and Brivaracetam Intravenous Bolus Injection (100 mg) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01796899
- Acronym / sponsor ID
- EP0007
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Brivaracetam
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 22 Feb 2013 (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 investigate the bioavailability/bioequivalence of Brivaracetam oral tablets (10 mg, 50 mg, 75 mg and 100 mg) and Brivaracetam intravenous injection (100 mg) in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam 10 mg oral tablet | Other | Other: Brivaracetam 10 mg oral tabletSubjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 10 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 10 mg * Form: Oral tablet * Frequency: Once daily * Duration: 1 day |
| Brivaracetam 50 mg oral tablet | Other | Other: Brivaracetam 50 mg oral tabletSubjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 50 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 50 mg * Form: Oral tablet * Frequency: Once daily * Duration: 1 day |
| Brivaracetam 75 mg oral tablet | Other | Other: Brivaracetam 75 mg oral tabletSubjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 75 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 75 mg * Form: Oral tablet * Frequency: Once daily * Duration: 1 day |
| Brivaracetam 100 mg oral tablet | Other | Other: Brivaracetam 100 mg oral tabletSubjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of BRV 100 mg oral tablet will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 100 mg * Form: Oral tablet * Frequency: Once daily * Duration: 1 day |
| 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL) | Other | Other: 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)Subjects check into the clinic the afternoon prior to the day of Brivaracetam (BRV) administration. The next day, a single dose of 10 mL of BRV intravenous bolus injection (10 mg/mL) will be administered in the morning. Following BRV administration, subjects will be observed for up to 48 hours. A Wash-Out Period of at least 7 days will separate the subsequent drug administrations. * Strength: 100 mg (10 mg/mL) * Form: Intravenous bolus injection * Frequency: Once daily * Duration: 1 day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is a healthy male or female volunteer aged 18-55 years inclusive
- Subject has a Body Mass Index (BMI) of 18.0 - 30.0 kg/m^2 and a weight of at least 50 kg (males) or 45 kg (females)
- Subject has normal vital signs values, Electrocardiograms (ECGs) and clinical laboratory values
- Female subjects should have a negative pregnancy test or be of non-childbearing potential
Key exclusion criteria (3 listed)
- Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
- Volunteer is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- Subject has an intolerance or allergy against the compound or related drugs
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 |
|---|---|---|
| Brivaracetam 10 mg oral tablet | Other | Brivaracetam 10 mg oral tablet |
| Brivaracetam 50 mg oral tablet | Other | Brivaracetam 50 mg oral tablet |
| Brivaracetam 75 mg oral tablet | Other | Brivaracetam 75 mg oral tablet |
| Brivaracetam 100 mg oral tablet | Other | Brivaracetam 100 mg oral tablet |
| 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL) | Other | 10 mL of Brivaracetam intravenous bolus injection (10 mg/mL) |
Primary outcome
Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax)
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification dose-normalized to the 50 mg reference treatment (AUC[0-t])
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Area under the plasma concentration-time curve from zero to infinity dose-normalized to the 50 mg reference treatment (AUC)
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
4 secondary outcomes
Plasma half-life of Brivaracetam
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Time to reach the maximum plasma concentration of Brivaracetam (tmax)
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Apparent oral clearance of Brivaracetam (CL/F)
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose
Apparent volume of Brivaracetam distribution at the terminal elimination phase
Time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h 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 15 Apr 2013.
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 10 mg oral tablet, Brivaracetam 50 mg oral tablet and Brivaracetam 75 mg oral tablet 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 4 inclusion and 3 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 15 Apr 2013. 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?
Maximum plasma concentration of Brivaracetam dose-normalized to the 50 mg reference treatment (Cmax) (time frame: Pharmacokinetic samples will be taken predose and 5 min, 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 6 h, 9 h, 12 h, 24 h, 36 h, and 48 h post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2013; AzTrials last refreshed its copy on 8 Nov 2026.