Healthy Study ParticipantsPhase 1NCT05315947

A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants

A Phase 1 study testing brivaracetam in people with Healthy Study Participants, run by UCB Biopharma SRL at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants. Read more about this study

Who is it for?: Ages 20 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Study Participants
What is being tested?: brivaracetam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteJapan
Study dates: 4 Apr 2022to 13 May 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Study participant must be between 20 to 50 years of age (inclusive) at the time of signing the Informed Consent Form (ICF)
Study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a study participant has all 4 Japanese grandparents born in Japan)

Who cannot join

Study participant has used other drugs, including over-the-counter medications, herbal/traditional medicines, or dietary supplements (excluding medicines for external use),with the exception of paracetamol, within 14 days before first administration of IMP or has received a coronavirus disease 2019 (COVID-19) vaccine within 7 days of initiating IMP
Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first administration of Investigational Medicinal Product (IMP)
Study participant has a positive result for hepatitis B surface antigen, hepatitis C virus antibody test, human immunodeficiency virus antibody test, or syphilis at Screening Visit
Study participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
Study participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
Consumption of more than 600 mg of caffeine/day (1 cup of coffee contains approximately 100mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola approximately 20 mg)

Trial locations and contacts

1 site in 1 country.

Japan1 site

EP0110 1
Sumida-ku

Other trials in Japan

About this study

Official title: A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants.

Conditions: Healthy Study Participants
Being tested: brivaracetam
Keywords: brivaracetam, Healthy Study Participants, Phase 1, BRV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

brivaracetamDrug
Also called BRV, Briviact
Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.
brivaracetamDrug
Also called BRV, Briviact
Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.

Study groups in NCT05315947
Study group	Role	What they receive
Treatment A-B	Experimental	Study participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints. Receives: Drug: brivaracetam
Treatment B-A	Experimental	Study participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints. Receives: Drug: brivaracetam

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam
Cmax is the maximum plasma concentration of brivaracetam.
Measured: 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
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam
AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.
Measured: 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

Secondary outcomes (2)

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
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.
Measured: From Baseline to end of Safety Follow-Up, up to 20 days
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE)
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.
Measured: From Baseline to end of Safety Follow-Up, up to 20 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 202213 May 2022

First posted7 Apr 2022
Study start4 Apr 2022
Primary completion13 May 2022
Study completion13 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy Study ParticipantsStudies of the same condition, open and under way.
More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05315947
Sponsor's protocol ID: EP0110
Status last verified: Mar 2023
First submitted: 14 Mar 2022
Last updated: 5 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Publications

Hayakawa Y, Yoshinaka R, Sano T, Krauwinkel W, Soma T, Sasamoto H, Elshoff JP, Bass A, Chen Y, Kurihara N, Murakami H. Bioequivalence and Safety Assessment of Brivaracetam Dry Syrup Compared With Tablets in Healthy Japanese Participants: Results From Two Randomized Single- and Multiple-Dose Trials. Clin Pharmacol Drug Dev. 2026 Apr;15(4):e70057. doi: 10.1002/cpdd.70057.
PubMed 41998831

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants
ClinicalTrials.gov ID: NCT05315947
Acronym / sponsor ID: EP0110
Conditions: Healthy Study Participants
Keywords: brivaracetam, Healthy Study Participants, Phase 1, BRV
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 4 Apr 2022 (actual)
Primary completion: 13 May 2022 (actual)
Study completion: 13 May 2022 (actual)
First posted: 7 Apr 2022 (actual)
Results: Posted 5 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment A-B	Experimental	Drug: brivaracetamStudy participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.
Treatment B-A	Experimental	Drug: brivaracetamStudy participants randomized to this arm will receive a single dose of brivaracetam tablet (Treatment A) as reference and single dose of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.

Who may qualify

Ages: 20 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Study participant must be between 20 to 50 years of age (inclusive) at the time of signing the Informed Consent Form (ICF)
Study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
Study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a study participant has all 4 Japanese grandparents born in Japan)

Key exclusion criteria (6 listed)

Study participant has used other drugs, including over-the-counter medications, herbal/traditional medicines, or dietary supplements (excluding medicines for external use),with the exception of paracetamol, within 14 days before first administration of IMP or has received a coronavirus disease 2019 (COVID-19) vaccine within 7 days of initiating IMP
Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first administration of Investigational Medicinal Product (IMP)
Study participant has a positive result for hepatitis B surface antigen, hepatitis C virus antibody test, human immunodeficiency virus antibody test, or syphilis at Screening Visit
Study participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
Study participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
brivaracetamAlso: BRV, BriviactStudy participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.	Drug	Treatment A-B, Treatment B-A
brivaracetamAlso: BRV, BriviactStudy participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.	Drug	Treatment A-B, Treatment B-A

Primary outcome

Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam
Time frame: 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
Cmax is the maximum plasma concentration of brivaracetam.
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam
Time frame: 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
AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.

2 secondary outcomes

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: From Baseline to end of Safety Follow-Up, up to 20 days
Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE)
Time frame: From Baseline to end of Safety Follow-Up, up to 20 days

Results and safety

Results posted to the registry on 5 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A-B (Sequence: BRV Tablet - BRV Dry Syrup)	12	12
Treatment B-A (Sequence: BRV Dry Syrup - BRV Tablet)	12	12

Primary outcome: Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliliter (μg/mL)

Measure	BRV Tablet n = 24	BRV Dry Syrup n = 24
Value	2.286 (24.5)	1.989 (22.4)

BRV Tablet vs BRV Dry Syrup: Ratio of Dry Syrup/ Tablet: 0.8700 (90% CI 0.7814 to 0.9686)

Population analysed: 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.

Primary outcome: Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam

Measure	BRV Tablet n = 24	BRV Dry Syrup n = 24
Value	17.98 (17.0)	17.78 (16.2)

BRV Tablet vs BRV Dry Syrup: Ratio of Dry Syrup/ Tablet: 0.9890 (90% CI 0.9756 to 1.003)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to end of Safety Follow-Up, up to 20 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BRV Tablet	0 of 24 (0%)	9 of 24 (37.5%)	0 of 24
BRV Dry Syrup	0 of 24 (0%)	8 of 24 (33.3%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41998831Hayakawa Y, Yoshinaka R, Sano T, Krauwinkel W, Soma T, Sasamoto H, Elshoff JP, Bass A, Chen Y, Kurihara N, Murakami H. Bioequivalence and Safety Assessment of Brivaracetam Dry Syrup Compared With Tablets in Healthy Japanese Participants: Results From Two Randomized Single- and Multiple-Dose Trials. Clin Pharmacol Drug Dev. 2026 Apr;15(4):e70057. doi: 10.1002/cpdd.70057.
Product InformationLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.
Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Cares study director

001 844 599 2273 (UCB)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing brivaracetam in people with Healthy Study Participants, run by UCB Biopharma SRL at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05315947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.