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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brivaracetam (BRV) tablet | Drug | Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EP0231 1 | Sumida-ku | Japan |
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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The Participant Flow refers to the Randomized Set.
The study started to enroll participants in March 2024 and concluded in June 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup | Dosing period 1 consisted of 5 days (Day -1 [1 day before administration of IMP] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg tablet formulation. Dosing period 2 consisted of 5 days (Day -1 [1 day before administration of IMP] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50mg as dry syrup twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. The final IMP administration in Dosing Period 1 and the first investigational medicinal product (IMP) administration in Dosing Period 2 were separated by a washout period of 6-10 days. |
| FG001 | Sequence BRV Dry Syrup - BRV Tablet | Dosing period 1 consisted of 5 days (Day -1 [1 day before administration of IMP] to Day 4): on Day 1 and Day 2 each participant received a dose of BRV 50 mg as dry syrup twice daily. On Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. Dosing period 2 consisted of 5 days (Day -1 [1 day before administration of IMP] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3 of Dosing Period 2, each participant received a single morning dose of BRV 50 mg tablet formulation. The final IMP administration in Dosing Period 1 and the first IMP administration in Dosing Period 2 were separated by a washout period of 6-10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup | Dosing period 1 consisted of 5 days (Day -1 [1 day before administration of IMP] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg tablet formulation. Dosing period 2 consisted of 5 days (Day -1 [1 day before administration of IMP] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50mg as dry syrup twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. The final IMP administration in Dosing Period 1 and the first investigational medicinal product (IMP) administration in Dosing Period 2 were separated by a washout period of 6-10 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Pharmacokinetic (PK) set included all participants who were randomized, received at least 1 dose of active IMP, and had at least 1 quantifiable post-baseline PK measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram per milliliter (μg/mL) | 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 |
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From Baseline to end of Safety Follow-Up (up to 25 days)
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 worsened in intensity following exposure to IMP. SS included all randomized participants who received at least 1 dose of the IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BRV Tablet | Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA ver 18.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2023 | May 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2024 | May 20, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C482793 | brivaracetam |
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| brivaracetam (BRV) dry syrup | Drug | Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally. |
|
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| 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. | 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. | From Baseline to end of Safety Follow-up (up to 25 days) |
| BG001 | Sequence BRV Dry Syrup - BRV Tablet | Dosing period 1 consisted of 5 days (Day -1 [1 day before administration of IMP] to Day 4): on Day 1 and Day 2 each participant received a dose of BRV 50 mg as dry syrup twice daily. On Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. Dosing period 2 consisted of 5 days (Day -1 [1 day before administration of IMP] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3 of Dosing Period 2, each participant received a single morning dose of BRV 50 mg tablet formulation. The final IMP administration in Dosing Period 1 and the first IMP administration in Dosing Period 2 were separated by a washout period of 6-10 days. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | BRV Dry Syrup | Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study. |
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| Primary | 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. | PK set included all participants who were randomized, received at least 1 dose of active IMP, and had at least 1 quantifiable post-Baseline PK measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*μg/mL | 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 |
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| Secondary | 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. | SS included all randomized participants who received at least 1 dose of the IMP. | Posted | Number | percentage of participants | From Baseline to end of Safety Follow-up (up to 25 days) |
|
|
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| Secondary | 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. | SS included all randomized participants who received at least 1 dose of the IMP. | Posted | Number | percentage of participants | From Baseline to end of Safety Follow-up (up to 25 days) |
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| Secondary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation | Percentage of participants with TEAEs leading to discontinuation were reported. | SS included all randomized participants who received at least 1 dose of the IMP. | Posted | Number | percentage of participants | From Baseline to end of Safety Follow-up (up to 25 days) |
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| 0 |
| 63 |
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| 63 |
| 2 |
| 63 |
| EG001 | BRV Dry Syrup | Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study. | 0 | 64 | 0 | 64 | 6 | 64 |
| Somnolence | Nervous system disorders | MedDRA ver 18.1 | Non-systematic Assessment |
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