Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects (NCT NCT04882540)
NCT ID: NCT04882540
Last Updated: 2023-03-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Results posted on
2023-03-13
Participant Flow
The study started to enroll study participants in May 2021 and concluded in June 2021.
Participant Flow refers to the Safety Set.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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12
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects
Baseline characteristics by cohort
| Measure |
Brivaracetam
n=12 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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12 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Age, Continuous
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29.9 years
STANDARD_DEVIATION 7.4 • n=5 Participants
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Sex: Female, Male
Female
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6 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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12 Participants
n=5 Participants
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Race/Ethnicity, Customized
Not Hispanic or Latino
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12 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
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|---|---|
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: Predose
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NA nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Means, standard deviation (SDs) and coefficient of variation (CVs) were only calculated if at least 2/3 of the concentrations are above lower limit of quantification (LLOQ).
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 0.25 hour postdose
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1039 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 134
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 0.50 hour postdose
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2610 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 46.2
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 1 hour postdose
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2725 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 19.6
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 1.5 hours postdose
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2458 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 15.9
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 2 hours postdose
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2602 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 18.2
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 3 hours postdose
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2387 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 21.3
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 4 hours postdose
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2181 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 22.8
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 6 hours postdose
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1793 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 22.4
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 9 hours postdose
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1389 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 27.8
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 12 hours postdose
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1064 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 28.8
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 16 hours postdose
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747.7 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32.7
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 24 hours postdose
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423.8 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 45.9
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 36 hours postdose
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157.6 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 64.4
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 48 hours postdose
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68.75 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 86.6
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
BRV- Day 1: 72 hours postdose
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9.372 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 229
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: Predose
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NA nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
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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
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4.480 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 131
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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
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27.48 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 66.8
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 1 hour postdose
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78.18 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 31.8
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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
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130.5 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 19.6
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 2 hours postdose
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155.9 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 22.8
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 3 hours postdose
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187.8 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 30.3
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 4 hours postdose
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149.4 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 21.8
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 6 hours postdose
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122.5 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 16.5
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 9 hours postdose
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112.6 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 25.0
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 12 hours postdose
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75.73 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 26.3
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 16 hours postdose
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59.17 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 26.6
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 24 hours postdose
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37.46 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 38.4
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 36 hours postdose
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12.82 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 50.8
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 48 hours postdose
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6.222 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 64.1
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-42145- Day 1: 72 hours postdose
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NA nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb-100406-1- Day 1: Predose
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NA nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
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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
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7.364 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 146
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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
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29.78 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 88.5
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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
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39.97 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 81.2
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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
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44.11 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 78.5
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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
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52.59 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 84.7
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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
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63.15 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 83.9
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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
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73.57 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 85.1
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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
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87.58 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 85.6
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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
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91.89 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 88.2
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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
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86.76 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 88.6
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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
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78.88 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 87.0
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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
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52.44 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 86.2
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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
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22.54 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 77.8
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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
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10.35 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 72.1
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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)
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
ucb107092-1- Day 1: Predose
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NA nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
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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)
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
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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)
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
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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
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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
|
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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
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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
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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
|
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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
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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
|
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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
|
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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 22.0
|
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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
|
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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
|
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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 29.0
|
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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)
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
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PRIMARY outcome
Timeframe: 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 postdosePopulation: 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.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
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Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose
BRV- Day 5: Predose
|
NA ng/mL
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
|
|
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
|
|
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
|
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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
|
|
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
|
|
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
|
|
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 54.0
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
|
|
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
|
|
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 26.0
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 27.0
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
|
|
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
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 76.0
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 75.0
|
|
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
Geometric Coefficient of Variation NA
Means, SDs and CVs were only calculated if at least 2/3 of the concentrations are above LLOQ.
|
|
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 22.0
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 20.0
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 32.0
|
|
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 outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
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.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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 outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Cmax was defined as the maximum observed plasma concentration.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose
|
3334 ng/mL
Geometric Coefficient of Variation 22.2
|
PRIMARY outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdosePopulation: 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.
AUC(0-12),ss was defined as the area under the plasma concentration-time curve from 0 to 12 hours at steady state.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Cmax,ss was defined as the maximum plasma concentration at steady state.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose
|
5215 ng/mL
Geometric Coefficient of Variation 27.7
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Tmax was defined as the time to reach maximum concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
Interval 0.5 to 3.0
|
|
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
Interval 1.5 to 6.0
|
|
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
Interval 6.0 to 12.0
|
|
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
Interval 4.0 to 9.0
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
t1/2 was defined as the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
λz was defined as the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 8.10
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
MRT was defined as the mean residence time.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose
|
13.02 hour
Geometric Coefficient of Variation 18.8
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
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.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
CL/F was defined as the apparent total body clearance.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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 outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Vz/F was defined as the apparent volume of distribution.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for Single Dose
|
37.69 Liter
Geometric Coefficient of Variation 10.8
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Cmax was defined as the maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
Cmax of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose
ucb-100406-1
|
93.16 ng/mL
Geometric Coefficient of Variation 88.0
|
|
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 outcome
Timeframe: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
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.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
tmax is the time to reach maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
Brivaracetam
|
0.5000 hour
Interval 0.25 to 2.0
|
|
Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
ucb-42145
|
3.000 hour
Interval 2.0 to 4.0
|
|
Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
ucb-100406-1
|
1.500 hour
Interval 1.0 to 6.0
|
|
Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
ucb107092-1
|
4.000 hour
Interval 0.0 to 6.02
|
SECONDARY outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
t1/2 is the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
λz is the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Cmin,ss is the minimum plasma concentration at steady state.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Cav,ss is the average plasma concentration at steady state.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
CLss/F is the apparent total body clearance at steady state.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Vz/F is the apparent volume of distribution.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
Vz/F of Brivaracetam in Plasma for Multiple Dose
|
39.65 Liter
Geometric Coefficient of Variation 14.8
|
SECONDARY outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Cmax,ss is the maximum plasma concentration at steady state. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
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
|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdosePopulation: 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.
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.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
|
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 70.0
|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
PTF was calculated as (Cmax,ss-Cmin,ss)/Cav,ss.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose
|
1.131 ratio
Geometric Coefficient of Variation 24.2
|
SECONDARY outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdosePopulation: 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.
Accumulation ratio (RAUC) was calculated as AUC(0-12),ss divided by AUC(0-12).
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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 outcome
Timeframe: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdosePopulation: 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.
Accumulation ratio (Rmax) was calculated as Cmax,ss divided by Cmax.
Outcome measures
| Measure |
Brivaracetam
n=12 Participants
Participants received a single dose of BRV 100 mg, orally on Day 1 in the single dose period.
|
|---|---|
|
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
|
Adverse Events
Brivaracetam
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brivaracetam
n=12 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Neutrophilia
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Cardiac disorders
Atrioventricular block first degree
|
8.3%
1/12 • Number of events 2 • 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.
|
|
Cardiac disorders
Ventricular extrasystoles
|
8.3%
1/12 • Number of events 2 • 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.
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
4/12 • Number of events 5 • 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.
|
|
General disorders
Asthenia
|
25.0%
3/12 • Number of events 4 • 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.
|
|
General disorders
Feeling drunk
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Investigations
Electrocardiogram QT prolonged
|
25.0%
3/12 • Number of events 4 • 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.
|
|
Investigations
Blood pressure decreased
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Nervous system disorders
Dizziness
|
83.3%
10/12 • Number of events 15 • 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.
|
|
Nervous system disorders
Somnolence
|
58.3%
7/12 • Number of events 11 • 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.
|
|
Nervous system disorders
Ataxia
|
25.0%
3/12 • Number of events 3 • 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.
|
|
Renal and urinary disorders
Haematuria
|
8.3%
1/12 • Number of events 1 • 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.
|
|
Renal and urinary disorders
Leukocyturia
|
8.3%
1/12 • Number of events 1 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60