Healthy Study ParticipantsPhase 1NCT06312566
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants
A Phase 1 study testing brivaracetam (BRV) tablet and brivaracetam (BRV) dry syrup in people with Healthy Study Participants, run by UCB Biopharma SRL at 1 site in Japan.
Trial summary
The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Study Participants
- What is being tested?
- brivaracetam (BRV) tablet and brivaracetam (BRV) dry syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteJapan
- Study dates
- 25 Mar 2024to 4 Jun 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF)
- Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan)
- Participant is male
Who cannot join
- Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations
- Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device)
- Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1
- Participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
- Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants
The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.
- Conditions
- Healthy Study Participants
- Being tested
- brivaracetam (BRV) tablet, brivaracetam (BRV) dry syrup
- Keywords
- brivaracetam, Healthy Study Participants, Phase 1, BRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brivaracetam (BRV) tabletDrug
Also called BRV, Briviact
Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.
brivaracetam (BRV) dry syrupDrug
Also called BRV
Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A-B | Experimental | Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints. Receives: Drug: brivaracetam (BRV) tablet; Drug: brivaracetam (BRV) dry syrup |
| Treatment B-A | Experimental | Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints. Receives: Drug: brivaracetam (BRV) tablet; Drug: brivaracetam (BRV) dry syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam
Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.
Measured: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam
AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.
Measured: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
Secondary outcomes (3)
Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP.
Measured: From Baseline to end of Safety Follow-up (up to 25 days)
Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)
A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:
Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Is a congenital anomaly or birth defect, Results in persistent disability/incapacity Is an infection that requires treatment parenteral antibiotics, Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Measured: From Baseline to end of Safety Follow-up (up to 25 days)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation
Percentage of participants with TEAEs leading to discontinuation were reported.
Measured: From Baseline to end of Safety Follow-up (up to 25 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start25 Mar 2024
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Study ParticipantsStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312566
- Sponsor's protocol ID
- EP0231
- Status last verified
- May 2025
- First submitted
- 8 Mar 2024
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants
- ClinicalTrials.gov ID
- NCT06312566
- Acronym / sponsor ID
- EP0231
- Conditions
- Healthy Study Participants
- Keywords
- brivaracetam, Healthy Study Participants, Phase 1, BRV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A-B | Experimental | Drug: brivaracetam (BRV) tablet, Drug: brivaracetam (BRV) dry syrupStudy participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints. |
| Treatment B-A | Experimental | Drug: brivaracetam (BRV) tablet, Drug: brivaracetam (BRV) dry syrupStudy participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF)
- Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan)
- Participant is male
Key exclusion criteria (5 listed)
- Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations
- Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device)
- Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1
- Participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
- Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
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 (BRV) tabletAlso: BRV, BriviactStudy participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally. | Drug | Treatment A-B, Treatment B-A |
| brivaracetam (BRV) dry syrupAlso: BRVStudy participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally. | Drug | Treatment A-B, Treatment B-A |
Primary outcome
Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam
Time frame: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.
Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam
Time frame: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.
3 secondary outcomes
Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline to end of Safety Follow-up (up to 25 days)
Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From Baseline to end of Safety Follow-up (up to 25 days)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation
Time frame: From Baseline to end of Safety Follow-up (up to 25 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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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 Cares study director
001 844 599 2273 (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 (BRV) tablet and brivaracetam (BRV) dry syrup in people with Healthy Study Participants, run by UCB Biopharma SRL at 1 site in Japan.
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 3 inclusion and 5 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 6 Jun 2025. 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 Japan. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam (time frame: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose). The study lists 2 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 6 Jun 2025.