Clinical trial NCT06312566: A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants
Official title: A Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Study Participants
Keywords: brivaracetam
Healthy Study Participants
Phase 1
BRV
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 64
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam
timeFrame: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
measure: Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam
timeFrame: Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose
Secondary outcomes:
measure: Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline to end of Safety Follow-up (up to 25 days)
measure: Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: From Baseline to end of Safety Follow-up (up to 25 days)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation
timeFrame: From Baseline to end of Safety Follow-up (up to 25 days)
Other outcomes:
Locations:
city: Sumida-ku
country: Japan
facility: EP0231 1
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: