NCT04882540 is a Phase 1 clinical trial of brivaracetam in Healthy Participants, sponsored by UCB Biopharma SRL.

Who is sponsoring NCT04882540?

NCT04882540 is sponsored by UCB Biopharma SRL.

What drugs are being tested in NCT04882540?

Interventions in NCT04882540: brivaracetam.

What condition does NCT04882540 study?

NCT04882540 studies Healthy Participants.

Is NCT04882540 still recruiting?

NCT04882540 is currently completed. Last updated 13 March 2023.

Are results published for NCT04882540?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-13 · How we verify

NCT04882540

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects

Completed Phase 1 Results posted Last updated 13 March 2023

What this trial tests

Phase 1 trial testing brivaracetam in Healthy Participants in 12 participants. Completed in 8 June 2021.

Timeline

19 May 2021

Primary endpoint
8 June 2021

8 June 2021

Quick facts

Lead sponsor	UCB Biopharma SRL
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	19 May 2021
Primary completion	8 June 2021
Estimated completion	8 June 2021
Sites	1 location across China

Drugs / interventions tested

brivaracetam (BRIVARACETAM) — full drug profile →

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

UCB Biopharma SRL — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy 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.

Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose Primary · Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

BRV- Day 1: Predose

Group	Value	95% CI
Brivaracetam	NA	± NA

BRV- Day 1: 0.25 hour postdose

Group	Value	95% CI
Brivaracetam	1039	± 134

BRV- Day 1: 0.50 hour postdose

Group	Value	95% CI
Brivaracetam	2610	± 46.2

BRV- Day 1: 1 hour postdose

Group	Value	95% CI
Brivaracetam	2725	± 19.6

BRV- Day 1: 1.5 hours postdose

Group	Value	95% CI
Brivaracetam	2458	± 15.9

BRV- Day 1: 2 hours postdose

Group	Value	95% CI
Brivaracetam	2602	± 18.2

BRV- Day 1: 3 hours postdose

Group	Value	95% CI
Brivaracetam	2387	± 21.3

BRV- Day 1: 4 hours postdose

Group	Value	95% CI
Brivaracetam	2181	± 22.8

Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose Primary · Predose on Day 5, 6, 7, 8, and 9; Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

BRV- Day 5: Predose

Group	Value	95% CI
Brivaracetam	NA	± NA

BRV- Day 6: Predose

Group	Value	95% CI
Brivaracetam	1743	± 33.6

BRV- Day 7: Predose

Group	Value	95% CI
Brivaracetam	1981	± 36.3

BRV- Day 8: Predose

Group	Value	95% CI
Brivaracetam	1955	± 38.4

BRV- Day 9: Predose

Group	Value	95% CI
Brivaracetam	1975	± 41.7

BRV- Day 10: Predose

Group	Value	95% CI
Brivaracetam	1918	± 34.2

BRV- Day 10: 0.25 hour postdose

Group	Value	95% CI
Brivaracetam	2888	± 54.0

BRV- Day 10: 0.5 hour postdose

Group	Value	95% CI
Brivaracetam	4582	± 45.6

Area Under the Plasma Concentration-time Curve From Zero to the Time of the Last Measured Concentration Above the Limit of Quantification (AUC(0-t)) of Brivaracetam for Single Dose Primary · Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

AUC(0-t) was defined as the area under the plasma concentration-time curve from zero to the time of the last measured concentration above the limit of quantification.

Group	Value	95% CI
Brivaracetam	35730	± 28.7

Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose Primary · Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

Cmax was defined as the maximum observed plasma concentration.

Group	Value	95% CI
Brivaracetam	3334	± 22.2

Area Under the Plasma Concentration-time Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Brivaracetam for Multiple Dose Primary · Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose

AUC(0-12),ss was defined as the area under the plasma concentration-time curve from 0 to 12 hours at steady state.

Group	Value	95% CI
Brivaracetam	36760	± 27.8

Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose Primary · Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

Cmax,ss was defined as the maximum plasma concentration at steady state.

Group	Value	95% CI
Brivaracetam	5215	± 27.7

Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study Primary · From Baseline to the end of Safety Follow-up (approximately 6 weeks)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs (TEAEs) were defined as those events that start on or after the time of first investigatio

Group	Value	95% CI
Brivaracetam	12

Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose Secondary · Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

Tmax was defined as the time to reach maximum concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.

Brivaracetam

Group	Value	95% CI
Brivaracetam	1.000	0.500 – 3.00

ucb-42145

Group	Value	95% CI
Brivaracetam	3.000	1.50 – 6.00

ucb-100406-1

Group	Value	95% CI
Brivaracetam	9.000	6.00 – 12.0

ucb107092-1

Group	Value	95% CI
Brivaracetam	6.000	4.00 – 9.00

Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose Secondary · Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

t1/2 was defined as the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.

Brivaracetam

Group	Value	95% CI
Brivaracetam	9.628	± 2.229

ucb-42145

Group	Value	95% CI
Brivaracetam	10.40	± 2.716

ucb-100406-1

Group	Value	95% CI
Brivaracetam	10.24	± 1.696

ucb107092-1

Group	Value	95% CI
Brivaracetam	12.38	± 1.019

Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose Secondary · Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

λz was defined as the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.

Brivaracetam

Group	Value	95% CI
Brivaracetam	0.07370	± 22.7

ucb-42145

Group	Value	95% CI
Brivaracetam	0.06866	± 25.3

ucb-100406-1

Group	Value	95% CI
Brivaracetam	0.06847	± 15.9

ucb107092-1

Group	Value	95% CI
Brivaracetam	0.05614	± 8.10

Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose Secondary · Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

MRT was defined as the mean residence time.

Group	Value	95% CI
Brivaracetam	13.02	± 18.8

Area Under the Plasma Concentration-time Curve From 0 to Infinite Time (AUC) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose Secondary · Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

AUC was defined as the area under the plasma concentration-time curve from 0 to infinite time. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.

Brivaracetam

Group	Value	95% CI
Brivaracetam	36000	± 29.1

ucb-42145

Group	Value	95% CI
Brivaracetam	2567	± 25.4

ucb-100406-1

Group	Value	95% CI
Brivaracetam	2530	± 81.5

ucb107092-1

Group	Value	95% CI
Brivaracetam	878.2	± 21.1

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day 1 to the end of Safety Follow-up (approximately 6 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brivaracetam

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (15 terms — click to expand)

Reaction	System	Brivaracetam
Dizziness	Nervous system disorders	—
Somnolence	Nervous system disorders	—
Diarrhoea	Gastrointestinal disorders	—
Asthenia	General disorders	—
Electrocardiogram QT prolonged	Investigations	—
Ataxia	Nervous system disorders	—
Neutrophilia	Blood and lymphatic system disorders	—
Atrioventricular block first degree	Cardiac disorders	—
Ventricular extrasystoles	Cardiac disorders	—
Palpitations	Cardiac disorders	—
Vertigo	Ear and labyrinth disorders	—
Feeling drunk	General disorders	—
Blood pressure decreased	Investigations	—
Haematuria	Renal and urinary disorders	—
Leukocyturia	Renal and urinary disorders	—

Data from ClinicalTrials.gov NCT04882540 adverse events section.

Sponsor's own description

The purpose of the study is to assess the pharmacokinetics, safety, and tolerability of brivaracetam after a single dose and multiple doses in healthy adult Chinese Study Participants.

Publications & conference data

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

Pathophysiology to Risk Factor and Therapeutics to Treatment Strategies on Epilepsy.
Boleti APA, Cardoso PHO, Frihling BEF, de Moraes LFRN, et al · · 2024 · cited 14× · PMID 38248286 · DOI 10.3390/brainsci14010071

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04882540 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by UCB Biopharma SRL
Last refreshed: 13 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04882540.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04882540

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of brivaracetam

Other recruiting trials for Healthy Participants

Other UCB Biopharma SRL trials

Verify against primary sources