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

UCB

Status and phase: Completed; Phase 1

Conditions: Healthy Study Participants

Treatments: Drug: brivaracetam (BRV) tablet; Drug: brivaracetam (BRV) dry syrup

Study type: Interventional

Funder types: Industry

Identifiers

NCT06312566

EP0231

Details and patient eligibility

About

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.

Enrollment: 64 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF)
• Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan)
• Participant is male

Exclusion criteria

• Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations
• Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device)
• Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1
• 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
• Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Treatment A-B

Experimental group

Description:

Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.

Treatment:

Drug: brivaracetam (BRV) dry syrup

Drug: brivaracetam (BRV) tablet

Treatment B-A

Experimental group

Description:

Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.

Treatment:

Drug: brivaracetam (BRV) dry syrup

Drug: brivaracetam (BRV) tablet