A Phase 1 interventional study of brivaracetam and brivaracetam 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 2024-01-05.
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 as dry syrup after a single oral dose in healthy Japanese male study 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 a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.
Drug: brivaracetam
Study participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.
Drug: brivaracetam
Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.
Also known as: BRV, Briviact
Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.
Also known as: BRV, Briviact
Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam
Cmax is the maximum plasma concentration of brivaracetam.
Time frame: Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam
AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.
Time frame: Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
An AE was defined as 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 20 days
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE)
A TEAE was 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, 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 20 days
The study started to enroll participants in April 2022 and concluded in May 2022.
| Milestone | Treatment A-B (Sequence: BRV Tablet - BRV Dry Syrup) | Treatment B-A (Sequence: BRV Dry Syrup - BRV Tablet) |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Cmax is the maximum plasma concentration of brivaracetam.
| micrograms per milliliter (μg/mL) | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam | 2.286 ± 24.5 | 1.989 ± 22.4 |
AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.
| hours*μg/mL | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam | 17.98 ± 17.0 | 17.78 ± 16.2 |
An AE was defined as 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 Participants With at Least One Treatment-emergent Adverse Event (TEAE) | 37.5 | 37.5 |
A TEAE was 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, 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 Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) | 0 | 0 |
Collected over From Baseline to end of Safety Follow-Up, up to 20 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BRV Tablet | 0/24 (0%) | 0/24 (0%) | 9/24 (37.5%) |
| BRV Dry Syrup | 0/24 (0%) | 0/24 (0%) | 8/24 (33.3%) |
| Event | BRV Tablet | BRV Dry Syrup |
|---|---|---|
| SomnolenceNervous system disorders | 7/24 | 6/24 |
| DizzinessNervous system disorders | 5/24 | 3/24 |
Baseline Characteristics refer to the Safety Set (SS) which consisted of all randomized study participants who received at least 1 dose of the investigational medicinal product (IMP).
| Age, Categorical(Participants) | BRV (All Participants) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 24 |
| >=65 years | 0 |
| Age, Continuous(years) | BRV (All Participants) |
|---|---|
| Mean | 34.5 ± 8.7 |
| Sex: Female, Male(Participants) | BRV (All Participants) |
|---|---|
| Female | 0 |
| Male | 24 |
| Race/Ethnicity, Customized(Participants) | BRV (All Participants) |
|---|---|
| Asian | 24 |
| Race/Ethnicity, Customized(Participants) | BRV (All Participants) |
|---|---|
| Not Hispanic or Latino | 24 |
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.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
UCB Biopharma SRL