NCT05315947

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

Completed Phase 1 Results posted Last updated 5 January 2024

What this trial tests

Phase 1 trial testing brivaracetam in Healthy Study Participants in 24 participants. Completed in 13 May 2022.

Timeline

4 April 2022

Primary endpoint
13 May 2022

13 May 2022

Quick facts

Lead sponsor	UCB Biopharma SRL
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	24
Start date	4 April 2022
Primary completion	13 May 2022
Estimated completion	13 May 2022
Sites	1 location across Japan

Drugs / interventions tested

• brivaracetam (BRIVARACETAM) — full drug profile →
• brivaracetam (BRIVARACETAM) — full drug profile →

Conditions studied

• Healthy Study Participants — all drugs for Healthy Study Participants →

Sponsor

UCB Biopharma SRL — full company profile →

Who can join

Adults 20 to 50, male only, with Healthy Study Participants. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Cmax is the maximum plasma concentration of brivaracetam.

Group	Value	95% CI
BRV Tablet	2.286	± 24.5
BRV Dry Syrup	1.989	± 22.4

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

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

Group	Value	95% CI
BRV Tablet	17.98	± 17.0
BRV Dry Syrup	17.78	± 16.2

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) Secondary · From Baseline to end of Safety Follow-Up, up to 20 days

An AE was defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP.

Group	Value	95% CI
BRV Tablet	37.5
BRV Dry Syrup	37.5

Percentage of Participants With at Least One Treatment-emergent Serious Adverse Event (SAE) Secondary · From Baseline to end of Safety Follow-Up, up to 20 days

A TEAE was any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization,Is a congenital anomaly or birth defect, Is an infection that requires treatment parenteral antibiotics, Other important medical events which based on medical or scientific judgement may je

Group	Value	95% CI
BRV Tablet	0
BRV Dry Syrup	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From Baseline to end of Safety Follow-Up, up to 20 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BRV Tablet

Serious: 0/24 (0%)

Deaths: 0/24

BRV Dry Syrup

Serious: 0/24 (0%)

Deaths: 0/24

Other adverse events (2 terms — click to expand)

Reaction	System	BRV Tablet	BRV Dry Syrup
Somnolence	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT05315947 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bioequivalence and Safety Assessment of Brivaracetam Dry Syrup Compared With Tablets in Healthy Japanese Participants: Results From Two Randomized Single- and Multiple-Dose Trials.
   Hayakawa Y, Yoshinaka R, Sano T, Krauwinkel W, et al · · 2026 · PMID 41998831 · DOI 10.1002/cpdd.70057