Epilepsy brivaracetam, Healthy Study Participants, Phase 1
Conditions
Interventions
Study participants will receive a single-dose of brivaractam tablet(reference -Treatment A)administered orally.
Study participants will receive a single-dose of brivaractam dry syrup (test -Treatment
Sponsors
Sasamoto Hiroshi
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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 19(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 Investigation Medical 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 >=400mL within 90 days, >=200mL 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 600mg of caffeine/day (1 cup of coffee contains approximately 100mg of caffeine, 1 cup of tea approximately 30mg, and 1 glass of cola approximately 20mg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Maximum plasma concentration (Cmax) for a single dose 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of participants with at least one treatment-emergent adverse event (TEAE) - Percentage of participants with at least one treatment-emergent serious adverse event (SAE) | — |
Contacts
Public ContactGlobal Clinical Development Japan
Global Clinical Development Japan
Outcome results
None listed