A Phase 1 interventional study of brivaracetam (BRV) tablet and brivaracetam (BRV) dry syrup in Healthy Study Participants, sponsored by UCB Biopharma SRL. Completed at 1 site in Japan. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by UCB Biopharma SRL · Phase 1, Interventional, and Basic science
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.
UCB Biopharma SRL is the lead sponsor of 128 studies on the registry; 19 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 48 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: brivaracetam (BRV) tablet · Drug: brivaracetam (BRV) dry syrup
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.
Drug: brivaracetam (BRV) tablet · Drug: brivaracetam (BRV) dry syrup
Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.
Also known as: BRV, Briviact
Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.
Also known as: BRV
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.
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
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.
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
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.
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)
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.
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
Percentage of participants with TEAEs leading to discontinuation were reported.
Time frame: From Baseline to end of Safety Follow-up (up to 25 days)
The study started to enroll participants in March 2024 and concluded in June 2024.
| Milestone | Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup | Sequence BRV Dry Syrup - BRV Tablet |
|---|---|---|
| Started | 32 | 32 |
| Completed | 32 | 31 |
| Not completed | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.
| microgram per milliliter (μg/mL) | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam | 2.963 ± 24.1 | 2.878 ± 19.5 |
AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.
| hours*μg/mL | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam | 18.55 ± 17.4 | 18.53 ± 16.8 |
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.
| percentage of participants | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) | 4.8 | 10.9 |
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.
| percentage of participants | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 0 | 0 |
Percentage of participants with TEAEs leading to discontinuation were reported.
| percentage of participants | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation | 0 | 0 |
Collected over From Baseline to end of Safety Follow-Up (up to 25 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BRV Tablet | 0/63 (0%) | 0/63 (0%) | 2/63 (3.2%) |
| BRV Dry Syrup | 0/64 (0%) | 0/64 (0%) | 6/64 (9.4%) |
| Event | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| DizzinessNervous system disorders | 2/63 | 3/64 |
| SomnolenceNervous system disorders | 1/63 | 3/64 |
Baseline characteristics refers to the safety set (SS) which included all randomized participants who received at least 1 dose of the investigational medicinal product (IMP).
| Age, Continuous(years) | Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup | Sequence BRV Dry Syrup - BRV Tablet | Total |
|---|---|---|---|
| Mean | 33.5 ± 9.8 | 33.8 ± 9.1 | 33.6 ± 9.4 |
| Age, Customized(Participants) | Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup | Sequence BRV Dry Syrup - BRV Tablet | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| 19 - 65 years | 32 | 32 | 64 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup | Sequence BRV Dry Syrup - BRV Tablet | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 32 | 32 | 64 |
| Race/Ethnicity, Customized(Participants) | Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup | Sequence BRV Dry Syrup - BRV Tablet | Total |
|---|---|---|---|
| Asian | 32 | 32 | 64 |
| Race/Ethnicity, Customized(Participants) | Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup | Sequence BRV Dry Syrup - BRV Tablet | Total |
|---|---|---|---|
| Not Hispanic or Latino | 32 | 32 | 64 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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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