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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A-B | Experimental | 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. |
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| Treatment B-A | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brivaracetam | Drug | Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam | Cmax is the maximum plasma concentration of brivaracetam. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 |
|---|---|---|---|---|---|---|
| EP0110 1 | Sumida-ku | Japan |
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| Label | URL |
|---|---|
| Product Information | View source |
| FDA Safety Alerts and Recalls | View source |
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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 April 2022 and concluded in May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A-B (Sequence: BRV Tablet - BRV Dry Syrup) | Participants randomized to this arm first received a single dose of brivaracetam (BRV) 50 milligrams (mg) tablet (reference), administered orally, in the morning under fasting conditions on Day 1 of Dosing Period 1. After a washout period of 7 to 10 days, participants received a single dose of BRV 50 mg as dry syrup (test), administered orally, in the morning under fasting conditions on Day 1 of Dosing Period 2. Both dosing periods were of 4 days, each with a single administration on Day 1 of each Dosing Period. |
| FG001 | Treatment B-A (Sequence: BRV Dry Syrup - BRV Tablet) | Participants randomized to this arm first received a single dose of BRV 50 mg as dry syrup (test), administered orally, in the morning under fasting conditions on Day 1 of Dosing Period 1. After a washout period of 7 to 10 days, participants received a single dose of BRV 50 mg tablet (reference), administered orally, in the morning under fasting conditions on Day 1 of Dosing Period 2. Both dosing periods were of 4 days, each with a single administration on Day 1 of each Dosing Period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | BRV (All Participants) | All participants received a single dose of either BRV 50 mg tablet or BRV 50 mg as dry syrup, orally, in the morning under fasting conditions on Day 1 of Dosing Period 1. After a washout period of 7 to 10 days, all participants received a single dose of either BRV 50 mg tablet or BRV 50 mg as dry syrup, orally, in the morning under fasting conditions on Day 1 of Dosing Period 2. Each dosing period is of 4 days, with a single administration on Day 1 of Dosing Period. |
| 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, Categorical | Count of Participants |
| 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 (Cmax) for a Single Dose of Brivaracetam | Cmax is the maximum plasma concentration of brivaracetam. | Pharmacokinetic Per Protocol Set (PK-PPS) included all randomized study participants who were included in the SS, had no important protocol deviations (IPDs) that were considered to impact the data validity for analysis of the primary study objective, and had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary pharmacokinetic parameters for both treatments. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | 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 |
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From Baseline to end of Safety Follow-Up, up to 20 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 worsens in intensity following exposure to IMP. Safety Set (SS) included all randomized study 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 who received a single administration of BRV 50 mg tablet, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA version 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 | Jan 11, 2022 | Mar 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 8, 2022 | Mar 24, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C482793 | brivaracetam |
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| brivaracetam | Drug | Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally. |
|
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| 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. | From Baseline to end of Safety Follow-Up, up to 20 days |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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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 who received a single administration of BRV 50 mg as dry syrup, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study. |
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| Primary | 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. | Pharmacokinetic Per Protocol Set (PK-PPS) included all randomized study participants who were included in the SS, had no important protocol deviations (IPDs) that were considered to impact the data validity for analysis of the primary study objective, and had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary pharmacokinetic parameters for both treatments. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*μg/mL | 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 |
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| Secondary | 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. | Safety Set (SS) included all randomized study 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 20 days |
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| Secondary | 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. | Safety Set (SS) included all randomized study 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 20 days |
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| 0 |
| 24 |
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| 24 |
| 9 |
| 24 |
| EG001 | BRV Dry Syrup | Participants who received a single administration of BRV 50 mg as dry syrup, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study. | 0 | 24 | 0 | 24 | 8 | 24 |
| Dizziness | Nervous system disorders | MedDRA version 18.1 | Non-systematic Assessment |
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