臨床研究等提出・公開システム

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 (A study to assess the bioequivalence between brivaracetam tablet and dry syrup in healthy male Japanese study participants)

A study to assess the bioequivalence between brivaracetam tablet and dry syrup in healthy male Japanese study participants

Sasamoto Hiroshi

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

CTR-JRCT.UCBJapan@ucb.com

Global Clinical Development Japan

Global Clinical Development Japan

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo

+81-3-6864-7587

CTR_SCC_UCBJapan@ucb.com

Not Recruiting

April. 01, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

basic science

- 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).

- 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).

Male

Epilepsy

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 B)administered orally.

brivaracetam, Healthy Study Participants, Phase 1

- 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.

- 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)

+81-92-283-7701

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.

none