Trial Outcomes & Findings for A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants (NCT NCT05315947)
NCT ID: NCT05315947
Last Updated: 2024-01-05
Results Overview
Cmax is the maximum plasma concentration of brivaracetam.
COMPLETED
PHASE1
24 participants
Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose
2024-01-05
Participant Flow
The study started to enroll participants in April 2022 and concluded in May 2022.
The Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Treatment A-B (Sequence: BRV Tablet - BRV Dry Syrup)
Participants randomized to this arm first received a single dose of brivaracetam (BRV) 50 milligrams (mg) tablet (reference), administered orally, in the morning under fasting conditions on Day 1 of Dosing Period 1. After a washout period of 7 to 10 days, participants received a single dose of BRV 50 mg as dry syrup (test), administered orally, in the morning under fasting conditions on Day 1 of Dosing Period 2. Both dosing periods were of 4 days, each with a single administration on Day 1 of each Dosing Period.
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Treatment B-A (Sequence: BRV Dry Syrup - BRV Tablet)
Participants randomized to this arm first received a single dose of BRV 50 mg as dry syrup (test), administered orally, in the morning under fasting conditions on Day 1 of Dosing Period 1. After a washout period of 7 to 10 days, participants received a single dose of BRV 50 mg tablet (reference), administered orally, in the morning under fasting conditions on Day 1 of Dosing Period 2. Both dosing periods were of 4 days, each with a single administration on Day 1 of each Dosing Period.
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|---|---|---|
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Overall Study
STARTED
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12
|
12
|
|
Overall Study
COMPLETED
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12
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12
|
|
Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
Baseline characteristics by cohort
| Measure |
BRV (All Participants)
n=24 Participants
All participants received a single dose of either BRV 50 mg tablet or BRV 50 mg as dry syrup, orally, in the morning under fasting conditions on Day 1 of Dosing Period 1. After a washout period of 7 to 10 days, all participants received a single dose of either BRV 50 mg tablet or BRV 50 mg as dry syrup, orally, in the morning under fasting conditions on Day 1 of Dosing Period 2. Each dosing period is of 4 days, with a single administration on Day 1 of Dosing Period.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
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Age, Continuous
|
34.5 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
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Sex: Female, Male
Female
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0 Participants
n=99 Participants
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Sex: Female, Male
Male
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24 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Asian
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24 Participants
n=99 Participants
|
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Race/Ethnicity, Customized
Not Hispanic or Latino
|
24 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic Per Protocol Set (PK-PPS) included all randomized study participants who were included in the SS, had no important protocol deviations (IPDs) that were considered to impact the data validity for analysis of the primary study objective, and had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary pharmacokinetic parameters for both treatments.
Cmax is the maximum plasma concentration of brivaracetam.
Outcome measures
| Measure |
BRV Tablet
n=24 Participants
Participants who received a single administration of BRV 50 mg tablet, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
|
BRV Dry Syrup
n=24 Participants
Participants who received a single administration of BRV 50 mg as dry syrup, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
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|---|---|---|
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Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam
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2.286 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 24.5
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1.989 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 22.4
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PRIMARY outcome
Timeframe: Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdosePopulation: Pharmacokinetic Per Protocol Set (PK-PPS) included all randomized study participants who were included in the SS, had no important protocol deviations (IPDs) that were considered to impact the data validity for analysis of the primary study objective, and had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary pharmacokinetic parameters for both treatments.
AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.
Outcome measures
| Measure |
BRV Tablet
n=24 Participants
Participants who received a single administration of BRV 50 mg tablet, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
|
BRV Dry Syrup
n=24 Participants
Participants who received a single administration of BRV 50 mg as dry syrup, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
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|---|---|---|
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Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam
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17.98 hours*μg/mL
Geometric Coefficient of Variation 17.0
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17.78 hours*μg/mL
Geometric Coefficient of Variation 16.2
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SECONDARY outcome
Timeframe: From Baseline to end of Safety Follow-Up, up to 20 daysPopulation: Safety Set (SS) included all randomized study participants who received at least 1 dose of the IMP.
An AE was defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP.
Outcome measures
| Measure |
BRV Tablet
n=24 Participants
Participants who received a single administration of BRV 50 mg tablet, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
|
BRV Dry Syrup
n=24 Participants
Participants who received a single administration of BRV 50 mg as dry syrup, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
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|---|---|---|
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Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
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37.5 percentage of participants
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37.5 percentage of participants
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SECONDARY outcome
Timeframe: From Baseline to end of Safety Follow-Up, up to 20 daysPopulation: Safety Set (SS) included all randomized study participants who received at least 1 dose of the IMP.
A TEAE was any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization,Is a congenital anomaly or birth defect, Is an infection that requires treatment parenteral antibiotics, Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Outcome measures
| Measure |
BRV Tablet
n=24 Participants
Participants who received a single administration of BRV 50 mg tablet, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
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BRV Dry Syrup
n=24 Participants
Participants who received a single administration of BRV 50 mg as dry syrup, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
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|---|---|---|
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Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE)
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0 percentage of participants
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0 percentage of participants
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Adverse Events
BRV Tablet
BRV Dry Syrup
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BRV Tablet
n=24 participants at risk
Participants who received a single administration of BRV 50 mg tablet, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
|
BRV Dry Syrup
n=24 participants at risk
Participants who received a single administration of BRV 50 mg as dry syrup, under fasting conditions on either Day 1 of Dosing Period 1 or Day 1 of Dosing Period 2 of the study.
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|---|---|---|
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Nervous system disorders
Somnolence
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29.2%
7/24 • Number of events 7 • From Baseline to end of Safety Follow-Up, up to 20 days
A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. Safety Set (SS) included all randomized study participants who received at least 1 dose of the IMP.
|
25.0%
6/24 • Number of events 6 • From Baseline to end of Safety Follow-Up, up to 20 days
A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. Safety Set (SS) included all randomized study participants who received at least 1 dose of the IMP.
|
|
Nervous system disorders
Dizziness
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20.8%
5/24 • Number of events 5 • From Baseline to end of Safety Follow-Up, up to 20 days
A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. Safety Set (SS) included all randomized study participants who received at least 1 dose of the IMP.
|
12.5%
3/24 • Number of events 3 • From Baseline to end of Safety Follow-Up, up to 20 days
A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. Safety Set (SS) included all randomized study participants who received at least 1 dose of the IMP.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60