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

NCT06312566 | Completed Phase 1 Results DMC

• 1 other identifier: EP0231
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Study Participants

Keywords

brivaracetam; Healthy Study Participants; Phase 1; BRV

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam

  Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.

  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

• Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam

  AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.

  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 (3)

• Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)

  From Baseline to end of Safety Follow-up (up to 25 days)

• Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)

  From Baseline to end of Safety Follow-up (up to 25 days)

• Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation

  From Baseline to end of Safety Follow-up (up to 25 days)

Study Arms (2)

Treatment A-B

EXPERIMENTAL

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.

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

Treatment B-A

EXPERIMENTAL

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.

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

Interventions

brivaracetam (BRV) tablet DRUG

Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.

Also known as: BRV, Briviact

Treatment A-B; Treatment B-A

brivaracetam (BRV) dry syrup DRUG

Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.

Also known as: BRV

Treatment A-B; Treatment B-A

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

EP0231 1

Sumida-ku, Japan

Location

MeSH Terms

Interventions

brivaracetam

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: March 25, 2024
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)