Healthy ParticipantsPhase 1NCT04882540

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

A Phase 1 study testing brivaracetam in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: brivaracetam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: 19 May 2021to 8 Jun 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator
Subjects are Chinese males and females born in China between 18 and 45 years of age (both inclusive) whose parents are of Chinese origin
Subjects with body mass index (BMI) from 19 to 24 kg/m^2 (both inclusive). Minimum body weight is equal to or more than 50 kg
Subjects with supine blood pressure levels of between 90 to 150 and 60 to 90 mmHg (inclusive) for systolic and diastolic, respectively, with pulse rate of 50 to 100 beats per minute (bpm) (supine position, inclusive) at Screening Visit
Subjects without clinically relevant abnormalities in a standard 12-lead Electrocardiogram (ECG) at Screening Visit judged by the Investigators
Subjects with laboratory values within the reference range at Screening Visit, or those with values exceeding the reference range but judged by the Investigators to be not clinically significant to their participation in the study

Who cannot join

Subject has participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 30 days or is currently participating in another study of an IMP (or a medical device)
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
Pregnant, lactating, or sexually active women with childbearing potential who are not using a medically accepted birth control method
Subject has a known hypersensitivity to any components of the IMP or any of its excipients
Subjects with any previous or current cardiovascular, respiratory, hepatic, renal, digestive, endocrine, or nervous system disorder that may affect absorption, secretion, metabolism, or excretion of the investigational product per Investigator judgement
Subjects showing a positive result for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis test at Screening Visit

Trial locations and contacts

1 site in 1 country.

China1 site

Ep0101 101
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of a Single and Multiple Oral Doses of Brivaracetam in Healthy Adult Chinese Subjects

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.

Conditions: Healthy Participants
Being tested: brivaracetam
Keywords: Epilepsy, Healthy participants, Phase 1, Brivaracetam
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

brivaracetamDrug
Also called Briviact
- Pharmaceutical form: Film-coated tablets
- Concentration: 100 mg tablets
- Route of administration: Oral use

Study groups in NCT04882540
Study group	Role	What they receive
brivaracetam	Experimental	This is a Single-Arm study with Single- and Multiple- Dose Periods. Study participants will receive a single dose of brivaracetam (BRV) on Day 1 and will then receive multiple doses of brivaracetam from Day 5-10. Receives: Drug: brivaracetam

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose
Measured: 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
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
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.
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose
Cmax was defined as the maximum observed plasma concentration.
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Brivaracetam for Multiple Dose
AUC(0-12),ss was defined as the area under the plasma concentration-time curve from 0 to 12 hours at steady state.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose
Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose
Cmax,ss was defined as the maximum plasma concentration at steady state.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
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 investigational medicinal product (IMP) administration, or whose severity worsens on or after the date of first administration of the IMP.
Measured: From Baseline to the end of Safety Follow-up (approximately 6 weeks)

Secondary outcomes (21)

Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose
Tmax was defined as the time to reach maximum concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose
t1/2 was defined as the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose
λz was defined as the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose
MRT was defined as the mean residence time.
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
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
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.
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Total Body Clearance (CL/F) of Brivaracetam in Plasma for Single Dose
CL/F was defined as the apparent total body clearance.
Measured: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for Single Dose
Vz/F was defined as the apparent volume of distribution.
Measured: 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 of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose
Cmax was defined as the maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: 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) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose
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. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: 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 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
tmax is the time to reach maximum plasma concentration. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
t1/2 is the terminal elimination half-life. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
λz is the rate constant of elimination. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Minimum Plasma Concentration at Steady State (Cmin,ss) of Brivaracetam in Plasma for Multiple Dose
Cmin,ss is the minimum plasma concentration at steady state.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Average Plasma Concentration at Steady State (Cav,ss) of Brivaracetam in Plasma for Multiple Dose
Cav,ss is the average plasma concentration at steady state.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Total Body Clearance at Steady State (CLss/F) of Brivaracetam in Plasma for Multiple Dose
CLss/F is the apparent total body clearance at steady state.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Vz/F of Brivaracetam in Plasma for Multiple Dose
Vz/F is the apparent volume of distribution.
Measured: 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 of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose
Cmax,ss is the maximum plasma concentration at steady state. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Area Under the Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
AUC(0-12),ss is the area under the curve from 0 to 12 hours at steady state. ucb-42145, ucb-100406-1, and ucb107092-1 are the metabolites of brivaracetam.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose
Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose
PTF was calculated as (Cmax,ss-Cmin,ss)/Cav,ss.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Accumulation Ratio Calculated From AUC at Steady State and AUC After Single Dose (RAUC) of Brivaracetam for Multiple Dose
Accumulation ratio (RAUC) was calculated as AUC(0-12),ss divided by AUC(0-12).
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose
Accumulation Ratio Calculated From Cmax at Steady State and Cmax After Single Dose (Rmax) of Brivaracetam for Multiple Dose
Accumulation ratio (Rmax) was calculated as Cmax,ss divided by Cmax.
Measured: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 20218 Jun 2021

First posted12 May 2021
Study start19 May 2021
Primary completion8 Jun 2021
Study completion8 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04882540
Sponsor's protocol ID: EP0101
Status last verified: May 2022
First submitted: 6 May 2021
Last updated: 13 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Single-arm Study to Evaluate the Pharmacokinetics and Safety of a Single and Multiple Oral Doses of Brivaracetam in Healthy Adult Chinese Subjects
ClinicalTrials.gov ID: NCT04882540
Acronym / sponsor ID: EP0101
Conditions: Healthy Participants
Keywords: Epilepsy, Healthy participants, Phase 1, Brivaracetam
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: UCB Biopharma SRLIndustry (pharma, biotech, devices)
Study start: 19 May 2021 (actual)
Primary completion: 8 Jun 2021 (actual)
Study completion: 8 Jun 2021 (actual)
First posted: 12 May 2021 (actual)
Results: Posted 13 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
brivaracetam	Experimental	Drug: brivaracetamThis is a Single-Arm study with Single- and Multiple- Dose Periods. Study participants will receive a single dose of brivaracetam (BRV) on Day 1 and will then receive multiple doses of brivaracetam from Day 5-10.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject
Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, or medication intake according to the judgment of the Investigator
Subjects are Chinese males and females born in China between 18 and 45 years of age (both inclusive) whose parents are of Chinese origin
Subjects with body mass index (BMI) from 19 to 24 kg/m^2 (both inclusive). Minimum body weight is equal to or more than 50 kg
Subjects with supine blood pressure levels of between 90 to 150 and 60 to 90 mmHg (inclusive) for systolic and diastolic, respectively, with pulse rate of 50 to 100 beats per minute (bpm) (supine position, inclusive) at Screening Visit

Key exclusion criteria (6 listed)

Subject has participated in another study of an investigational medicinal product (IMP) (or a medical device) within the previous 30 days or is currently participating in another study of an IMP (or a medical device)
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
Pregnant, lactating, or sexually active women with childbearing potential who are not using a medically accepted birth control method
Subject has a known hypersensitivity to any components of the IMP or any of its excipients
Subjects with any previous or current cardiovascular, respiratory, hepatic, renal, digestive, endocrine, or nervous system disorder that may affect absorption, secretion, metabolism, or excretion of the investigational product per Investigator judgement

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
brivaracetamAlso: Briviact* Pharmaceutical form: Film-coated tablets * Concentration: 100 mg tablets * Route of administration: Oral use	Drug	brivaracetam

Primary outcome

Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose
Time frame: 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
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
Time frame: 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.
Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose
Time frame: 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.
Area Under the Plasma Concentration-time Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Brivaracetam for Multiple Dose
Time frame: 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.
Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose
Time frame: 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.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Time frame: 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 investigational medicinal product (IMP) administration, or whose severity worsens on or after the date of first administration of the IMP.

21 secondary outcomes

Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
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
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Total Body Clearance (CL/F) of Brivaracetam in Plasma for Single Dose
Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for Single Dose
Time frame: 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 of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose
Time frame: 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) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose
Time frame: 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 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Minimum Plasma Concentration at Steady State (Cmin,ss) of Brivaracetam in Plasma for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Average Plasma Concentration at Steady State (Cav,ss) of Brivaracetam in Plasma for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Apparent Total Body Clearance at Steady State (CLss/F) of Brivaracetam in Plasma for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Vz/F of Brivaracetam in Plasma for Multiple Dose
Time frame: 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 of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Area Under the Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose
Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose
Accumulation Ratio Calculated From AUC at Steady State and AUC After Single Dose (RAUC) of Brivaracetam for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, and 12 hours postdose
Accumulation Ratio Calculated From Cmax at Steady State and Cmax After Single Dose (Rmax) of Brivaracetam for Multiple Dose
Time frame: Day 10: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

Results and safety

Results posted to the registry on 13 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brivaracetam	12	12

Primary outcome: Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose

Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms/milliliter (ng/mL)

Measure	Brivaracetam n = 12
BRV- Day 1: Predose	NA (NA)
BRV- Day 1: 0.25 hour postdose	1039 (134)
BRV- Day 1: 0.50 hour postdose	2610 (46.2)
BRV- Day 1: 1 hour postdose	2725 (19.6)
BRV- Day 1: 1.5 hours postdose	2458 (15.9)
BRV- Day 1: 2 hours postdose	2602 (18.2)
BRV- Day 1: 3 hours postdose	2387 (21.3)
BRV- Day 1: 4 hours postdose	2181 (22.8)

Population analysed: The PK-PPS consisted of all participants who were included in the safety set and also had a sufficient number of bioanalytical assessments to calculate reliable estimates for the primary PK parameters.

Primary outcome: Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Brivaracetam n = 12
BRV- Day 5: Predose	NA (NA)
BRV- Day 6: Predose	1743 (33.6)
BRV- Day 7: Predose	1981 (36.3)
BRV- Day 8: Predose	1955 (38.4)
BRV- Day 9: Predose	1975 (41.7)
BRV- Day 10: Predose	1918 (34.2)
BRV- Day 10: 0.25 hour postdose	2888 (54.0)
BRV- Day 10: 0.5 hour postdose	4582 (45.6)

Primary outcome: 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

Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hours*nanograms per milliliter (h*ng/mL)

Measure	Brivaracetam n = 12
Value	35730 (28.7)

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose

Time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Brivaracetam n = 12
Value	3334 (22.2)

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 to the end of Safety Follow-up (approximately 6 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brivaracetam	0 of 12 (0%)	12 of 12 (100%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Cares study director

001 844 599 2273 (UCB)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing brivaracetam in people with Healthy Participants, run by UCB Biopharma SRL at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose (time frame: Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04882540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.