Healthy Participants
Conditions
Keywords
Epilepsy, Healthy participants, Phase 1, Brivaracetam
Brief summary
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.
Interventions
DRUGbrivaracetam
* Pharmaceutical form: Film-coated tablets * Concentration: 100 mg tablets * Route of administration: Oral use
Sponsors
UCB Biopharma SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject * Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator * Subjects are Chinese males and females born in China between 18 and 45 years of age (both inclusive) whose parents are of Chinese origin * Subjects with body mass index (BMI) from 19 to 24 kg/m\^2 (both inclusive). Minimum body weight is equal to or more than 50 kg * Subjects with supine blood pressure levels of between 90 to 150 and 60 to 90 mmHg (inclusive) for systolic and diastolic, respectively, with pulse rate of 50 to 100 beats per minute (bpm) (supine position, inclusive) at Screening Visit * Subjects without clinically relevant abnormalities in a standard 12-lead Electrocardiogram (ECG) at Screening Visit judged by the Investigators * Subjects with laboratory values within the reference range at Screening Visit, or those with values exceeding the reference range but judged by the Investigators to be not clinically significant to their participation in the study
Exclusion criteria
* Subject has participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 30 days or is currently participating in another study of an IMP (or a medical device) * Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study * Pregnant, lactating, or sexually active women with childbearing potential who are not using a medically accepted birth control method * Subject has a known hypersensitivity to any components of the IMP or any of its excipients * Subjects with any previous or current cardiovascular, respiratory, hepatic, renal, digestive, endocrine, or nervous system disorder that may affect absorption, secretion, metabolism, or excretion of the investigational product per Investigator judgement * Subjects showing a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis test at Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) 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. |
| Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for 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 | Cmax was defined as the maximum observed plasma concentration. |
| Area Under the Plasma Concentration-time Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Brivaracetam for Multiple Dose | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose | AUC(0-12),ss was defined as the area under the plasma concentration-time curve from 0 to 12 hours at steady state. |
| Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose | 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 was defined as the maximum plasma concentration at steady state. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | From Baseline to the end of Safety Follow-up (approximately 6 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of Ucb-42145, Ucb-100406-1 and ucb107092-1 for 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 | Cmax was defined as the maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. |
| AUC (0-t) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for 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 | 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. |
| Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose | tmax is the time to reach maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. |
| t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | 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 is the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. |
| λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | 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 is the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. |
| Minimum Plasma Concentration at Steady State (Cmin,ss) of Brivaracetam in Plasma for Multiple Dose | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose | Cmin,ss is the minimum plasma concentration at steady state. |
| Average Plasma Concentration at Steady State (Cav,ss) of Brivaracetam in Plasma for Multiple Dose | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose | Cav,ss is the average plasma concentration at steady state. |
| Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for 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 | Tmax was defined as the time to reach maximum concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. |
| Vz/F of Brivaracetam in Plasma for Multiple Dose | 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 is the apparent volume of distribution. |
| Cmax,ss of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose | 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 is the maximum plasma concentration at steady state. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. |
| 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 | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose | 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. |
| Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose | PTF was calculated as (Cmax,ss-Cmin,ss)/Cav,ss. |
| Accumulation Ratio Calculated From AUC at Steady State and AUC After Single Dose (RAUC) of Brivaracetam for Multiple Dose | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose | Accumulation ratio (RAUC) was calculated as AUC(0-12),ss divided by AUC(0-12). |
| Accumulation Ratio Calculated From Cmax at Steady State and Cmax After Single Dose (Rmax) of Brivaracetam for Multiple Dose | 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 (Rmax) was calculated as Cmax,ss divided by Cmax. |
| Apparent Total Body Clearance at Steady State (CLss/F) of Brivaracetam in Plasma for Multiple Dose | Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose | CLss/F is the apparent total body clearance at steady state. |
| Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for 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 | t1/2 was defined as the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. |
| Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for 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 | λz was defined as the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam. |
| Mean Residence Time (MRT) of Brivaracetam in Plasma for 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 | MRT was defined as the mean residence time. |
| 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 | 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 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. |
| Apparent Total Body Clearance (CL/F) of Brivaracetam in Plasma for 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 | CL/F was defined as the apparent total body clearance. |
| Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for 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 | Vz/F was defined as the apparent volume of distribution. |
Countries
China
Participant flow
Recruitment details
The study started to enroll study participants in May 2021 and concluded in June 2021.
Pre-assignment details
Participant Flow refers to the Safety Set.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Brivaracetam |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 29.9 years STANDARD_DEVIATION 7.4 |
| Race/Ethnicity, Customized Asian | 12 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 12 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 12 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Area Under the Plasma Concentration-time Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Brivaracetam for Multiple Dose | 36760 h*ng/mL | Geometric Coefficient of Variation 27.8 |
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.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | 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 | 35730 hours*nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 28.7 |
Primary
Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose
Cmax was defined as the maximum observed plasma concentration.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose | 3334 ng/mL | Geometric Coefficient of Variation 22.2 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose | 5215 ng/mL | Geometric Coefficient of Variation 27.7 |
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.
Time frame: From Baseline to the end of Safety Follow-up (approximately 6 weeks)
Population: The safety set consisted of all participants who received at least 1 dose of BRV.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brivaracetam | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study | 12 Participants |
Primary
Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 5: Predose | NA ng/mL | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 6: Predose | 1743 ng/mL | Geometric Coefficient of Variation 33.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 7: Predose | 1981 ng/mL | Geometric Coefficient of Variation 36.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 8: Predose | 1955 ng/mL | Geometric Coefficient of Variation 38.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 9: Predose | 1975 ng/mL | Geometric Coefficient of Variation 41.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: Predose | 1918 ng/mL | Geometric Coefficient of Variation 34.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 0.25 hour postdose | 2888 ng/mL | Geometric Coefficient of Variation 54 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 0.5 hour postdose | 4582 ng/mL | Geometric Coefficient of Variation 45.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 1 hour postdose | 4448 ng/mL | Geometric Coefficient of Variation 30.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 1.5 hour postdose | 4583 ng/mL | Geometric Coefficient of Variation 21.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 2 hours postdose | 4421 ng/mL | Geometric Coefficient of Variation 22.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 3 hours postdose | 4037 ng/mL | Geometric Coefficient of Variation 23.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 4 hours postdose | 3671 ng/mL | Geometric Coefficient of Variation 26.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 6 hours postdose | 2956 ng/mL | Geometric Coefficient of Variation 26.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 9 hours postdose | 2241 ng/mL | Geometric Coefficient of Variation 32.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 12 hours postdose | 1702 ng/mL | Geometric Coefficient of Variation 38.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 16 hours postdose | 1185 ng/mL | Geometric Coefficient of Variation 44.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 24 hours postdose | 614.7 ng/mL | Geometric Coefficient of Variation 57.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 36 hours postdose | 216.1 ng/mL | Geometric Coefficient of Variation 75.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 48 hours postdose | 93.68 ng/mL | Geometric Coefficient of Variation 95.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | BRV- Day 10: 72 hours postdose | 17.75 ng/mL | Geometric Coefficient of Variation 154 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 5: Predose | NA ng/mL | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 6: Predose | 153.6 ng/mL | Geometric Coefficient of Variation 25.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 7: Predose | 185.8 ng/mL | Geometric Coefficient of Variation 26 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 8: Predose | 181.1 ng/mL | Geometric Coefficient of Variation 28.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 9: Predose | 193.1 ng/mL | Geometric Coefficient of Variation 34.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: Predose | 166.6 ng/mL | Geometric Coefficient of Variation 34.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 0.25 hour postdose | 156.1 ng/mL | Geometric Coefficient of Variation 38.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 0.5 hour postdose | 177.0 ng/mL | Geometric Coefficient of Variation 35.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 1 hour postdose | 247.8 ng/mL | Geometric Coefficient of Variation 34.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 1.5 hour postdose | 265.2 ng/mL | Geometric Coefficient of Variation 28.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 2 hours postdose | 293.2 ng/mL | Geometric Coefficient of Variation 26.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 3 hours postdose | 357.2 ng/mL | Geometric Coefficient of Variation 21.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 4 hours postdose | 291.6 ng/mL | Geometric Coefficient of Variation 27 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 6 hours postdose | 199.9 ng/mL | Geometric Coefficient of Variation 24.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 9 hours postdose | 185.1 ng/mL | Geometric Coefficient of Variation 28.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 12 hours postdose | 123.7 ng/mL | Geometric Coefficient of Variation 32.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 16 hours postdose | 111.4 ng/mL | Geometric Coefficient of Variation 33.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 24 hours postdose | 54.35 ng/mL | Geometric Coefficient of Variation 42.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 36 hours postdose | 17.39 ng/mL | Geometric Coefficient of Variation 59.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 48 hours postdose | 9.114 ng/mL | Geometric Coefficient of Variation 67.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-42145- Day 10: 72 hours postdose | NA ng/mL | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 5: Predose | NA ng/mL | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 6: Predose | 146.9 ng/mL | Geometric Coefficient of Variation 78.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 7: Predose | 188.1 ng/mL | Geometric Coefficient of Variation 75.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 8: Predose | 209.2 ng/mL | Geometric Coefficient of Variation 72.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 9: Predose | 217.0 ng/mL | Geometric Coefficient of Variation 71.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: Predose | 218.2 ng/mL | Geometric Coefficient of Variation 71.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 0.25 hour postdose | 221.2 ng/mL | Geometric Coefficient of Variation 70.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 0.5 hour postdose | 238.2 ng/mL | Geometric Coefficient of Variation 67.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 1 hour postdose | 243.9 ng/mL | Geometric Coefficient of Variation 67.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 1.5 hours postdose | 258.2 ng/mL | Geometric Coefficient of Variation 70.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 2 hours postdose | 249.9 ng/mL | Geometric Coefficient of Variation 67.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 3 hours postdose | 248.3 ng/mL | Geometric Coefficient of Variation 69.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 4 hours postdose | 254.3 ng/mL | Geometric Coefficient of Variation 70.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 6 hours postdose | 238.7 ng/mL | Geometric Coefficient of Variation 68.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 9 hours postdose | 229.0 ng/mL | Geometric Coefficient of Variation 70.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 12 hours postdose | 212.2 ng/mL | Geometric Coefficient of Variation 76 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 16 hours postdose | 171.7 ng/mL | Geometric Coefficient of Variation 73.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 24 hours postdose | 111.6 ng/mL | Geometric Coefficient of Variation 72.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 36 hours postdose | 41.71 ng/mL | Geometric Coefficient of Variation 72.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 48 hours postdose | 19.41 ng/mL | Geometric Coefficient of Variation 66.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb-100406-1- Day 10: 72 hours postdose | 2.771 ng/mL | Geometric Coefficient of Variation 75 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 5: Predose | NA ng/mL | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 6: Predose | 51.71 ng/mL | Geometric Coefficient of Variation 22 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 7: Predose | 63.87 ng/mL | Geometric Coefficient of Variation 27.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 8: Predose | 65.14 ng/mL | Geometric Coefficient of Variation 25.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 9: Predose | 71.64 ng/mL | Geometric Coefficient of Variation 23.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: Predose | 68.47 ng/mL | Geometric Coefficient of Variation 23.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 0.25 hour postdose | 62.74 ng/mL | Geometric Coefficient of Variation 21.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 0.5 hour postdose | 63.76 ng/mL | Geometric Coefficient of Variation 19.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 1 hour postdose | 65.20 ng/mL | Geometric Coefficient of Variation 20 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 1.5 hours postdose | 68.84 ng/mL | Geometric Coefficient of Variation 22.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 2 hours postdose | 71.72 ng/mL | Geometric Coefficient of Variation 18.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 3 hours postdose | 82.18 ng/mL | Geometric Coefficient of Variation 20.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 4 hours postdose | 84.04 ng/mL | Geometric Coefficient of Variation 15.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 6 hours postdose | 80.87 ng/mL | Geometric Coefficient of Variation 20.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 9 hours postdose | 69.25 ng/mL | Geometric Coefficient of Variation 23.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 12 hours postdose | 52.96 ng/mL | Geometric Coefficient of Variation 17.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 16 hours postdose | 42.69 ng/mL | Geometric Coefficient of Variation 21.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 24 hours postdose | 28.57 ng/mL | Geometric Coefficient of Variation 25.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 36 hours postdose | 13.15 ng/mL | Geometric Coefficient of Variation 26.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 48 hours postdose | 8.580 ng/mL | Geometric Coefficient of Variation 32 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose | ucb107092-1- Day 10: 72 hours postdose | 3.380 ng/mL | Geometric Coefficient of Variation 52.9 |
Primary
Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: Predose | NA nanograms/milliliter (ng/mL) | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 0.25 hour postdose | 1039 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 134 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 0.50 hour postdose | 2610 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 46.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 1 hour postdose | 2725 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 19.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 1.5 hours postdose | 2458 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 15.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 2 hours postdose | 2602 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 18.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 3 hours postdose | 2387 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 21.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 4 hours postdose | 2181 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 22.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 6 hours postdose | 1793 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 22.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 9 hours postdose | 1389 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 27.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 12 hours postdose | 1064 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 28.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 16 hours postdose | 747.7 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 32.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 24 hours postdose | 423.8 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 45.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 36 hours postdose | 157.6 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 64.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 48 hours postdose | 68.75 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 86.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | BRV- Day 1: 72 hours postdose | 9.372 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 229 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: Predose | NA nanograms/milliliter (ng/mL) | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 0.25 hour postdose | 4.480 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 131 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 0.50 hour postdose | 27.48 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 66.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 1 hour postdose | 78.18 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 31.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 1.5 hours postdose | 130.5 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 19.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 2 hours postdose | 155.9 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 22.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 3 hours postdose | 187.8 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 30.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 4 hours postdose | 149.4 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 21.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 6 hours postdose | 122.5 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 16.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 9 hours postdose | 112.6 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 25 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 12 hours postdose | 75.73 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 26.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 16 hours postdose | 59.17 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 26.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 24 hours postdose | 37.46 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 38.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 36 hours postdose | 12.82 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 50.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 48 hours postdose | 6.222 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 64.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-42145- Day 1: 72 hours postdose | NA nanograms/milliliter (ng/mL) | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: Predose | NA nanograms/milliliter (ng/mL) | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 0.25 hour postdose | 7.364 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 146 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 0.5 hour postdose | 29.78 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 88.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 1 hour postdose | 39.97 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 81.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 1.5 hour postdose | 44.11 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 78.5 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 2 hours postdose | 52.59 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 84.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 3 hours postdose | 63.15 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 83.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 4 hours postdose | 73.57 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 85.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 6 hours postdose | 87.58 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 85.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 9 hours postdose | 91.89 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 88.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 12 hours postdose | 86.76 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 88.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 16 hours postdose | 78.88 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 87 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 24 hours postdose | 52.44 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 86.2 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 36 hours postdose | 22.54 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 77.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 48 hours postdose | 10.35 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 72.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb-100406-1- Day 1: 72 hours postdose | NA nanograms/milliliter (ng/mL) | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: Predose | NA nanograms/milliliter (ng/mL) | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 0.25 hour postdose | NA nanograms/milliliter (ng/mL) | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 0.5 hour postdose | NA nanograms/milliliter (ng/mL) | — |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 1 hour postdose | 4.404 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 62.9 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 1.5 hours postdose | 9.800 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 32.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 2 hours postdose | 16.17 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 22.6 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 3 hours postdose | 27.06 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 18.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 4 hours postdose | 37.89 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 22.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 6 hours postdose | 41.59 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 16.3 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 9 hours postdose | 38.77 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 25.1 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 12 hours postdose | 28.37 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 20.8 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 16 hours postdose | 21.85 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 22 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 24 hours postdose | 14.49 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 28.7 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 36 hours postdose | 6.443 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 23.4 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 48 hours postdose | 3.976 nanograms/milliliter (ng/mL) | Geometric Coefficient of Variation 29 |
| Brivaracetam | Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose | ucb107092-1- Day 1: 72 hours postdose | NA nanograms/milliliter (ng/mL) | — |
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).
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Accumulation Ratio Calculated From AUC at Steady State and AUC After Single Dose (RAUC) of Brivaracetam for Multiple Dose | 1.677 ratio | Geometric Coefficient of Variation 12.6 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Accumulation Ratio Calculated From Cmax at Steady State and Cmax After Single Dose (Rmax) of Brivaracetam for Multiple Dose | 1.564 ratio | Geometric Coefficient of Variation 30.4 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Apparent Total Body Clearance at Steady State (CLss/F) of Brivaracetam in Plasma for Multiple Dose | 2.720 L/h | Geometric Coefficient of Variation 27.8 |
Secondary
Apparent Total Body Clearance (CL/F) of Brivaracetam in Plasma for Single Dose
CL/F was defined as the apparent total body clearance.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Apparent Total Body Clearance (CL/F) of Brivaracetam in Plasma for Single Dose | 2.777 Liter per hour (L/h) | Geometric Coefficient of Variation 29.1 |
Secondary
Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for Single Dose
Vz/F was defined as the apparent volume of distribution.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for Single Dose | 37.69 Liter | Geometric Coefficient of Variation 10.8 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | 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 | ucb-42145 | 2644 h*ng/mL | Geometric Coefficient of Variation 23.5 |
| Brivaracetam | 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 | ucb-100406-1 | 2844 h*ng/mL | Geometric Coefficient of Variation 70 |
| Brivaracetam | 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 | ucb107092-1 | 867.1 h*ng/mL | Geometric Coefficient of Variation 18.3 |
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.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | 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 | Brivaracetam | 36000 h*ng/mL | Geometric Coefficient of Variation 29.1 |
| Brivaracetam | 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 | ucb-42145 | 2567 h*ng/mL | Geometric Coefficient of Variation 25.4 |
| Brivaracetam | 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 | ucb-100406-1 | 2530 h*ng/mL | Geometric Coefficient of Variation 81.5 |
| Brivaracetam | 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 | ucb107092-1 | 878.2 h*ng/mL | Geometric Coefficient of Variation 21.1 |
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.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | AUC (0-t) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb-42145 | 2503 h*ng/mL | Geometric Coefficient of Variation 25.4 |
| Brivaracetam | AUC (0-t) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb-100406-1 | 2423 h*ng/mL | Geometric Coefficient of Variation 85.2 |
| Brivaracetam | AUC (0-t) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb107092-1 | 799.2 h*ng/mL | Geometric Coefficient of Variation 21.1 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Average Plasma Concentration at Steady State (Cav,ss) of Brivaracetam in Plasma for Multiple Dose | 3064 ng/mL | Geometric Coefficient of Variation 27.8 |
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.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | Cmax of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose | ucb-42145 | 193.3 ng/mL | Geometric Coefficient of Variation 27.7 |
| Brivaracetam | Cmax of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose | ucb-100406-1 | 93.16 ng/mL | Geometric Coefficient of Variation 88 |
| Brivaracetam | Cmax of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose | ucb107092-1 | 43.18 ng/mL | Geometric Coefficient of Variation 21.1 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | Cmax,ss of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose | ucb-42145 | 357.9 ng/mL | Geometric Coefficient of Variation 21.6 |
| Brivaracetam | Cmax,ss of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose | ucb-100406-1 | 264.8 ng/mL | Geometric Coefficient of Variation 68.8 |
| Brivaracetam | Cmax,ss of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose | ucb107092-1 | 88.53 ng/mL | Geometric Coefficient of Variation 16.1 |
Secondary
Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose
MRT was defined as the mean residence time.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose | 13.02 hour | Geometric Coefficient of Variation 18.8 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Minimum Plasma Concentration at Steady State (Cmin,ss) of Brivaracetam in Plasma for Multiple Dose | 1696 ng/mL | Geometric Coefficient of Variation 38.2 |
Secondary
Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose
PTF was calculated as (Cmax,ss-Cmin,ss)/Cav,ss.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose | 1.131 ratio | Geometric Coefficient of Variation 24.2 |
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.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | Brivaracetam | 0.07370 1/hour | Geometric Coefficient of Variation 22.7 |
| Brivaracetam | Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb-42145 | 0.06866 1/hour | Geometric Coefficient of Variation 25.3 |
| Brivaracetam | Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb-100406-1 | 0.06847 1/hour | Geometric Coefficient of Variation 15.9 |
| Brivaracetam | Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb107092-1 | 0.05614 1/hour | Geometric Coefficient of Variation 8.1 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | Brivaracetam | 10.25 hour | Standard Deviation 1.749 |
| Brivaracetam | t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb-42145 | 10.15 hour | Standard Deviation 2.198 |
| Brivaracetam | t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb-100406-1 | 9.645 hour | Standard Deviation 1.067 |
| Brivaracetam | t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb107092-1 | 14.85 hour | Standard Deviation 2.334 |
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.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | Brivaracetam | 9.628 hour | Standard Deviation 2.229 |
| Brivaracetam | Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb-42145 | 10.40 hour | Standard Deviation 2.716 |
| Brivaracetam | Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb-100406-1 | 10.24 hour | Standard Deviation 1.696 |
| Brivaracetam | Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb107092-1 | 12.38 hour | Standard Deviation 1.019 |
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.
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Brivaracetam | Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | Brivaracetam | 1.000 hour |
| Brivaracetam | Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb-42145 | 3.000 hour |
| Brivaracetam | Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb-100406-1 | 9.000 hour |
| Brivaracetam | Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose | ucb107092-1 | 6.000 hour |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Brivaracetam | Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | Brivaracetam | 0.5000 hour |
| Brivaracetam | Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb-42145 | 3.000 hour |
| Brivaracetam | Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb-100406-1 | 1.500 hour |
| Brivaracetam | Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb107092-1 | 4.000 hour |
Secondary
Vz/F of Brivaracetam in Plasma for Multiple Dose
Vz/F is the apparent volume of distribution.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Brivaracetam | Vz/F of Brivaracetam in Plasma for Multiple Dose | 39.65 Liter | Geometric Coefficient of Variation 14.8 |
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.
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Brivaracetam | λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | Brivaracetam | 0.06860 1/hour | Geometric Coefficient of Variation 17.9 |
| Brivaracetam | λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb-42145 | 0.06984 1/hour | Geometric Coefficient of Variation 22.4 |
| Brivaracetam | λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb-100406-1 | 0.07228 1/hour | Geometric Coefficient of Variation 11.3 |
| Brivaracetam | λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose | ucb107092-1 | 0.04721 1/hour | Geometric Coefficient of Variation 16.5 |