Trial Outcomes & Findings for A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants (NCT NCT06312566)
NCT ID: NCT06312566
Last Updated: 2025-06-06
Results Overview
Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
Results posted on
2025-06-06
Participant Flow
The study started to enroll participants in March 2024 and concluded in June 2024.
The Participant Flow refers to the Randomized Set.
Participant milestones
| Measure |
Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup
Dosing period 1 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg tablet formulation. Dosing period 2 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50mg as dry syrup twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. The final IMP administration in Dosing Period 1 and the first investigational medicinal product (IMP) administration in Dosing Period 2 were separated by a washout period of 6-10 days.
|
Sequence BRV Dry Syrup - BRV Tablet
Dosing period 1 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): on Day 1 and Day 2 each participant received a dose of BRV 50 mg as dry syrup twice daily. On Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. Dosing period 2 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3 of Dosing Period 2, each participant received a single morning dose of BRV 50 mg tablet formulation. The final IMP administration in Dosing Period 1 and the first IMP administration in Dosing Period 2 were separated by a washout period of 6-10 days.
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|---|---|---|
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Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup
Dosing period 1 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg tablet formulation. Dosing period 2 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50mg as dry syrup twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. The final IMP administration in Dosing Period 1 and the first investigational medicinal product (IMP) administration in Dosing Period 2 were separated by a washout period of 6-10 days.
|
Sequence BRV Dry Syrup - BRV Tablet
Dosing period 1 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): on Day 1 and Day 2 each participant received a dose of BRV 50 mg as dry syrup twice daily. On Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. Dosing period 2 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3 of Dosing Period 2, each participant received a single morning dose of BRV 50 mg tablet formulation. The final IMP administration in Dosing Period 1 and the first IMP administration in Dosing Period 2 were separated by a washout period of 6-10 days.
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|---|---|---|
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Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants
Baseline characteristics by cohort
| Measure |
Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup
n=32 Participants
Dosing period 1 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg tablet formulation. Dosing period 2 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50mg as dry syrup twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. The final IMP administration in Dosing Period 1 and the first investigational medicinal product (IMP) administration in Dosing Period 2 were separated by a washout period of 6-10 days.
|
Sequence BRV Dry Syrup - BRV Tablet
n=32 Participants
Dosing period 1 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): on Day 1 and Day 2 each participant received a dose of BRV 50 mg as dry syrup twice daily. On Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. Dosing period 2 consisted of 5 days (Day -1 \[1 day before administration of IMP\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3 of Dosing Period 2, each participant received a single morning dose of BRV 50 mg tablet formulation. The final IMP administration in Dosing Period 1 and the first IMP administration in Dosing Period 2 were separated by a washout period of 6-10 days.
|
Total
n=64 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
33.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
33.8 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
33.6 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
19 - 65 years
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdosePopulation: Pharmacokinetic (PK) set included all participants who were randomized, received at least 1 dose of active IMP, and had at least 1 quantifiable post-baseline PK measurement.
Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.
Outcome measures
| Measure |
BRV Tablet
n=63 Participants
Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
BRV Dry Syrup
n=64 Participants
Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
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|---|---|---|
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Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam
|
2.963 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 24.1
|
2.878 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 19.5
|
PRIMARY outcome
Timeframe: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdosePopulation: PK set included all participants who were randomized, received at least 1 dose of active IMP, and had at least 1 quantifiable post-Baseline PK measurement.
AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.
Outcome measures
| Measure |
BRV Tablet
n=63 Participants
Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
BRV Dry Syrup
n=64 Participants
Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
|---|---|---|
|
Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam
|
18.55 hours*μg/mL
Geometric Coefficient of Variation 17.4
|
18.53 hours*μg/mL
Geometric Coefficient of Variation 16.8
|
SECONDARY outcome
Timeframe: From Baseline to end of Safety Follow-up (up to 25 days)Population: SS included all randomized participants who received at least 1 dose of the IMP.
An AE was 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=63 Participants
Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
BRV Dry Syrup
n=64 Participants
Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
|---|---|---|
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Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)
|
4.8 percentage of participants
|
10.9 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to end of Safety Follow-up (up to 25 days)Population: SS included all randomized participants who received at least 1 dose of 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. 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, Results in persistent disability/incapacity 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=63 Participants
Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
BRV Dry Syrup
n=64 Participants
Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
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|---|---|---|
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Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to end of Safety Follow-up (up to 25 days)Population: SS included all randomized participants who received at least 1 dose of the IMP.
Percentage of participants with TEAEs leading to discontinuation were reported.
Outcome measures
| Measure |
BRV Tablet
n=63 Participants
Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
BRV Dry Syrup
n=64 Participants
Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
BRV Tablet
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BRV Dry Syrup
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BRV Tablet
n=63 participants at risk
Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
BRV Dry Syrup
n=64 participants at risk
Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
3.2%
2/63 • Number of events 3 • From Baseline to end of Safety Follow-Up (up to 25 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 worsened in intensity following exposure to IMP. SS included all randomized participants who received at least 1 dose of the IMP.
|
4.7%
3/64 • Number of events 3 • From Baseline to end of Safety Follow-Up (up to 25 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 worsened in intensity following exposure to IMP. SS included all randomized participants who received at least 1 dose of the IMP.
|
|
Nervous system disorders
Somnolence
|
1.6%
1/63 • Number of events 1 • From Baseline to end of Safety Follow-Up (up to 25 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 worsened in intensity following exposure to IMP. SS included all randomized participants who received at least 1 dose of the IMP.
|
4.7%
3/64 • Number of events 3 • From Baseline to end of Safety Follow-Up (up to 25 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 worsened in intensity following exposure to IMP. SS included all randomized 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