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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Study Participants

Intervention / Treatment
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* Drug: brivaracetam
* Drug: brivaracetam


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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) Exclusion criteria: 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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A-B<br>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. | Drug: brivaracetam<br>* Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.<br>* Other names: Briviact;Drug: brivaracetam<br>* Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.<br>* Other names: Briviact;|
| Experimental: Treatment B-A<br>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. | Drug: brivaracetam<br>* Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.<br>* Other names: Briviact;Drug: brivaracetam<br>* Study participants will receive a single-dose of brivaractam dry syrup (test - Treatment B) administered orally.<br>* Other names: Briviact;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) for a single dose of brivaracetam | Cmax=maximum concentration | Blood samples for this analysis are collected on Day 1 at 0 (predose), 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)=area under the curve from 0 to the time of the last quantifiable concentration; | Blood samples for this analysis are collected on Day 1 at 0 (predose), 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with at least one treatment-emergent adverse event (TEAE) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | 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 serious adverse event (SAE) is 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. | From Baseline to end of Safety Follow-Up, up to 20 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brivaracetam, Healthy Study Participants, Phase 1, BRV