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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Study Participants

Treatments: Drug: brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05315947

EP0110

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Treatment A-B

Experimental group

Description:

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.

Treatment:

Drug: brivaracetam

Drug: brivaracetam

Treatment B-A

Experimental group

Description:

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.

Treatment:

Drug: brivaracetam

Drug: brivaracetam