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

NCT05315947 | Completed Phase 1 Results

• 1 other identifier: EP0110
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Study Participants

Keywords

brivaracetam; Healthy Study Participants; Phase 1; BRV

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax) for a Single Dose of Brivaracetam

  Cmax is the maximum plasma concentration of brivaracetam.

  Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose

• Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration (AUC(0-t)) for a Single Dose of Brivaracetam

  AUC(0-t) is the area under the curve from time 0 to the time of the last quantifiable concentration.

  Blood samples for this analysis were collected on Predose (Day 1), 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose

Secondary Outcomes (2)

• Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)

  From Baseline to end of Safety Follow-Up, up to 20 days

• Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE)

  From Baseline to end of Safety Follow-Up, up to 20 days

Study Arms (2)

Treatment A-B

EXPERIMENTAL

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.

Drug: brivaracetam

Treatment B-A

EXPERIMENTAL

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.

Drug: brivaracetam

Interventions

brivaracetam DRUG

Study participants will receive a single-dose of brivaractam tablet (reference - Treatment A) administered orally.

Also known as: BRV, Briviact

Treatment A-B; Treatment B-A

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

EP0110 1

Sumida-ku, Japan

Location

Related Links

• Product Information
• FDA Safety Alerts and Recalls

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 14, 2022
• First Posted: April 7, 2022
• Study Start: April 4, 2022
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)