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The purpose of the study is to assess the pharmacokinetics, safety, and tolerability of brivaracetam after a single dose and multiple doses in healthy adult Chinese Study Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brivaracetam | Experimental | This is a Single-Arm study with Single- and Multiple- Dose Periods. Study participants will receive a single dose of brivaracetam (BRV) on Day 1 and will then receive multiple doses of brivaracetam from Day 5-10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brivaracetam | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose | |
| Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | Predose on Day 5, 6, 7, 8, and 9; Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose | |
| Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measured Concentration Above the Limit of Quantification (AUC(0-t)) of Brivaracetam for Single Dose | AUC(0-t) was defined as the area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose | Cmax was defined as the maximum observed plasma concentration. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Area Under the Plasma Concentration-time Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Brivaracetam for Multiple Dose | AUC(0-12),ss was defined as the area under the plasma concentration-time curve from 0 to 12 hours at steady state. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose |
| Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose | Cmax,ss was defined as the maximum plasma concentration at steady state. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | Tmax was defined as the time to reach maximum concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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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 |
|---|---|---|---|---|---|---|
| Ep0101 101 | Shanghai | Shanghai Municipality | China |
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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Participant Flow refers to the Safety Set.
The study started to enroll study participants in May 2021 and concluded in June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brivaracetam | Participants received a single dose of brivaracetam (BRV) 100 milligrams (mg), orally on Day 1 in the single dose period and received BRV 200 mg/day, orally from Day 5 to 9 and 100 mg on Day 10 in the multiple dose period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The Safety Set consisted of all participants who received at least 1 dose of BRV.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brivaracetam | Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period and received BRV 200 mg/day, orally from Day 5 to 9 and 100 mg on Day 10 in the multiple dose 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 | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter (ng/mL) | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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From Day 1 to the end of Safety Follow-up (approximately 6 weeks)
Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which have onset or worsening severity (relative to pre-treatment) after the first dose of BRV.
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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 | Brivaracetam | Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period and received BRV 200 mg/day, orally from Day 5 to 9 and 100 mg on Day 10 in the multiple dose period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA v18.1 | 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 8, 2021 | May 25, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2021 | May 25, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C482793 | brivaracetam |
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| Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the time of first investigational medicinal product (IMP) administration, or whose severity worsens on or after the date of first administration of the IMP. | From Baseline to the end of Safety Follow-up (approximately 6 weeks) |
| Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | t1/2 was defined as the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | λz was defined as the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose | MRT was defined as the mean residence time. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Area Under the Plasma Concentration-time Curve From 0 to Infinite Time (AUC) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose | AUC was defined as the area under the plasma concentration-time curve from 0 to infinite time. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Apparent Total Body Clearance (CL/F) of Brivaracetam in Plasma for Single Dose | CL/F was defined as the apparent total body clearance. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for Single Dose | Vz/F was defined as the apparent volume of distribution. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Cmax of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose | Cmax was defined as the maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| AUC (0-t) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | AUC(0-t) was defined as the area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | tmax is the time to reach maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | t1/2 is the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | λz is the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Minimum Plasma Concentration at Steady State (Cmin,ss) of Brivaracetam in Plasma for Multiple Dose | Cmin,ss is the minimum plasma concentration at steady state. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Average Plasma Concentration at Steady State (Cav,ss) of Brivaracetam in Plasma for Multiple Dose | Cav,ss is the average plasma concentration at steady state. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Apparent Total Body Clearance at Steady State (CLss/F) of Brivaracetam in Plasma for Multiple Dose | CLss/F is the apparent total body clearance at steady state. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Vz/F of Brivaracetam in Plasma for Multiple Dose | Vz/F is the apparent volume of distribution. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Cmax,ss of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose | Cmax,ss is the maximum plasma concentration at steady state. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Area Under the Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | AUC(0-12),ss is the area under the curve from 0 to 12 hours at steady state. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose |
| Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose | PTF was calculated as (Cmax,ss-Cmin,ss)/Cav,ss. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| Accumulation Ratio Calculated From AUC at Steady State and AUC After Single Dose (RAUC) of Brivaracetam for Multiple Dose | Accumulation ratio (RAUC) was calculated as AUC(0-12),ss divided by AUC(0-12). | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose |
| Accumulation Ratio Calculated From Cmax at Steady State and Cmax After Single Dose (Rmax) of Brivaracetam for Multiple Dose | Accumulation ratio (Rmax) was calculated as Cmax,ss divided by Cmax. | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
| 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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| Participants |
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| Primary | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Predose on Day 5, 6, 7, 8, and 9; Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Primary | Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measured Concentration Above the Limit of Quantification (AUC(0-t)) of Brivaracetam for Single Dose | AUC(0-t) was defined as the area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours*nanograms per milliliter (h*ng/mL) | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose | Cmax was defined as the maximum observed plasma concentration. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Primary | Area Under the Plasma Concentration-time Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Brivaracetam for Multiple Dose | AUC(0-12),ss was defined as the area under the plasma concentration-time curve from 0 to 12 hours at steady state. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Least Squares Mean | Geometric Coefficient of Variation | h*ng/mL | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose |
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| Primary | Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose | Cmax,ss was defined as the maximum plasma concentration at steady state. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the time of first investigational medicinal product (IMP) administration, or whose severity worsens on or after the date of first administration of the IMP. | The safety set consisted of all participants who received at least 1 dose of BRV. | Posted | Count of Participants | Participants | From Baseline to the end of Safety Follow-up (approximately 6 weeks) |
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| Secondary | Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | Tmax was defined as the time to reach maximum concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Median | Full Range | hour | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | t1/2 was defined as the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. Here, number analyzed signifies those who were evaluable at the prespecified categories only. | Posted | Mean | Standard Deviation | hour | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | λz was defined as the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. Here, number analyzed signifies those who were evaluable at the prespecified categories only. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose | MRT was defined as the mean residence time. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Area Under the Plasma Concentration-time Curve From 0 to Infinite Time (AUC) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose | AUC was defined as the area under the plasma concentration-time curve from 0 to infinite time. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. Here, number analyzed signifies those who were evaluable at the prespecified categories only. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Apparent Total Body Clearance (CL/F) of Brivaracetam in Plasma for Single Dose | CL/F was defined as the apparent total body clearance. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/h) | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for Single Dose | Vz/F was defined as the apparent volume of distribution. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Cmax of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose | Cmax was defined as the maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | AUC (0-t) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | AUC(0-t) was defined as the area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | tmax is the time to reach maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Median | Full Range | hour | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | t1/2 is the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. Here, number analyzed signifies those who were evaluable at the prespecified categories only. | Posted | Mean | Standard Deviation | hour | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | λz is the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. Here, number analyzed signifies those who were evaluable at the prespecified categories only. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/hour | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Minimum Plasma Concentration at Steady State (Cmin,ss) of Brivaracetam in Plasma for Multiple Dose | Cmin,ss is the minimum plasma concentration at steady state. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Average Plasma Concentration at Steady State (Cav,ss) of Brivaracetam in Plasma for Multiple Dose | Cav,ss is the average plasma concentration at steady state. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Apparent Total Body Clearance at Steady State (CLss/F) of Brivaracetam in Plasma for Multiple Dose | CLss/F is the apparent total body clearance at steady state. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/h | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Vz/F of Brivaracetam in Plasma for Multiple Dose | Vz/F is the apparent volume of distribution. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Cmax,ss of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose | Cmax,ss is the maximum plasma concentration at steady state. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Area Under the Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | AUC(0-12),ss is the area under the curve from 0 to 12 hours at steady state. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose |
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| Secondary | Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose | PTF was calculated as (Cmax,ss-Cmin,ss)/Cav,ss. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| Secondary | Accumulation Ratio Calculated From AUC at Steady State and AUC After Single Dose (RAUC) of Brivaracetam for Multiple Dose | Accumulation ratio (RAUC) was calculated as AUC(0-12),ss divided by AUC(0-12). | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose |
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| Secondary | Accumulation Ratio Calculated From Cmax at Steady State and Cmax After Single Dose (Rmax) of Brivaracetam for Multiple Dose | Accumulation ratio (Rmax) was calculated as Cmax,ss divided by Cmax. | The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose |
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| 0 |
| 12 |
| 0 |
| 12 |
| 12 |
| 12 |
| Atrioventricular block first degree | Cardiac disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Feeling drunk | General disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDRA v18.1 | Non-systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA v18.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v18.1 | Non-systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDRA v18.1 | Non-systematic Assessment |
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Not provided
|
| BRV- Day 8: Predose |
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| BRV- Day 9: Predose |
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| BRV- Day 10: Predose |
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| BRV- Day 10: 0.25 hour postdose |
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| BRV- Day 10: 0.5 hour postdose |
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| BRV- Day 10: 1 hour postdose |
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| BRV- Day 10: 1.5 hour postdose |
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| BRV- Day 10: 2 hours postdose |
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| BRV- Day 10: 3 hours postdose |
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| BRV- Day 10: 4 hours postdose |
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| BRV- Day 10: 6 hours postdose |
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| BRV- Day 10: 9 hours postdose |
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| BRV- Day 10: 12 hours postdose |
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| BRV- Day 10: 16 hours postdose |
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| BRV- Day 10: 24 hours postdose |
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| BRV- Day 10: 36 hours postdose |
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| BRV- Day 10: 48 hours postdose |
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| BRV- Day 10: 72 hours postdose |
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| ucb-42145- Day 5: Predose |
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| ucb-42145- Day 6: Predose |
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| ucb-42145- Day 7: Predose |
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| ucb-42145- Day 8: Predose |
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| ucb-42145- Day 9: Predose |
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| ucb-42145- Day 10: Predose |
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| ucb-42145- Day 10: 0.25 hour postdose |
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| ucb-42145- Day 10: 0.5 hour postdose |
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| ucb-42145- Day 10: 1 hour postdose |
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| ucb-42145- Day 10: 1.5 hour postdose |
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| ucb-42145- Day 10: 2 hours postdose |
|
| ucb-42145- Day 10: 3 hours postdose |
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| ucb-42145- Day 10: 4 hours postdose |
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| ucb-42145- Day 10: 6 hours postdose |
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| ucb-42145- Day 10: 9 hours postdose |
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| ucb-42145- Day 10: 12 hours postdose |
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| ucb-42145- Day 10: 16 hours postdose |
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| ucb-42145- Day 10: 24 hours postdose |
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| ucb-42145- Day 10: 36 hours postdose |
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| ucb-42145- Day 10: 48 hours postdose |
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| ucb-42145- Day 10: 72 hours postdose |
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| ucb-100406-1- Day 5: Predose |
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| ucb-100406-1- Day 6: Predose |
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| ucb-100406-1- Day 7: Predose |
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| ucb-100406-1- Day 8: Predose |
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| ucb-100406-1- Day 9: Predose |
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| ucb-100406-1- Day 10: Predose |
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| ucb-100406-1- Day 10: 0.25 hour postdose |
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| ucb-100406-1- Day 10: 0.5 hour postdose |
|
| ucb-100406-1- Day 10: 1 hour postdose |
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| ucb-100406-1- Day 10: 1.5 hours postdose |
|
| ucb-100406-1- Day 10: 2 hours postdose |
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| ucb-100406-1- Day 10: 3 hours postdose |
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| ucb-100406-1- Day 10: 4 hours postdose |
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| ucb-100406-1- Day 10: 6 hours postdose |
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| ucb-100406-1- Day 10: 9 hours postdose |
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| ucb-100406-1- Day 10: 12 hours postdose |
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| ucb-100406-1- Day 10: 16 hours postdose |
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| ucb-100406-1- Day 10: 24 hours postdose |
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| ucb-100406-1- Day 10: 36 hours postdose |
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| ucb-100406-1- Day 10: 48 hours postdose |
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| ucb-100406-1- Day 10: 72 hours postdose |
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| ucb107092-1- Day 5: Predose |
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| ucb107092-1- Day 6: Predose |
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| ucb107092-1- Day 7: Predose |
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| ucb107092-1- Day 8: Predose |
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| ucb107092-1- Day 9: Predose |
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| ucb107092-1- Day 10: Predose |
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| ucb107092-1- Day 10: 0.25 hour postdose |
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| ucb107092-1- Day 10: 0.5 hour postdose |
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| ucb107092-1- Day 10: 1 hour postdose |
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| ucb107092-1- Day 10: 1.5 hours postdose |
|
| ucb107092-1- Day 10: 2 hours postdose |
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| ucb107092-1- Day 10: 3 hours postdose |
|
| ucb107092-1- Day 10: 4 hours postdose |
|
| ucb107092-1- Day 10: 6 hours postdose |
|
| ucb107092-1- Day 10: 9 hours postdose |
|
| ucb107092-1- Day 10: 12 hours postdose |
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| ucb107092-1- Day 10: 16 hours postdose |
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| ucb107092-1- Day 10: 24 hours postdose |
|
| ucb107092-1- Day 10: 36 hours postdose |
|
| ucb107092-1- Day 10: 48 hours postdose |
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| ucb107092-1- Day 10: 72 hours postdose |
|
| Title | Measurements |
|---|---|
|
| ucb107092-1 |
|
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| ucb-100406-1 |
|
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| ucb107092-1 |
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| ucb-100406-1 |
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| ucb107092-1 |
|
|
|
| ucb-100406-1 |
|
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| ucb107092-1 |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| ucb107092-1 |
|
|
| ucb-100406-1 |
|
|
| ucb107092-1 |
|
|
|
| ucb-100406-1 |
|
|
| ucb107092-1 |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|