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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
* Pharmaceutical form: Film-coated tablets * Concentration: 100 mg tablets * Route of administration: Oral use
Ep0101 101
Shanghai, Shanghai Municipality, China
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
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
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
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
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
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
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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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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