Phase 1
Completed N=12
A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects
Healthy Participants
Source: ClinicalTrials.gov NCT04882540 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose — NA; 1039; 2610; 2725 nanograms/milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Single Dose |
NA; 1039; 2610; 2725; 2458; 2602 | — |
| PRIMARY Plasma Concentration of BRV and Its Metabolites (Ucb-42145, Ucb-100406-1, ucb107092-1) After Multiple Dose |
NA; 1743; 1981; 1955; 1975; 1918 | — |
| PRIMARY 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 |
35730 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Brivaracetam for Single Dose |
3334 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From 0 to 12 Hours at Steady State (AUC(0-12),ss) of Brivaracetam for Multiple Dose |
36760 | — |
| PRIMARY Maximum Plasma Concentration at Steady State (Cmax,ss) of Brivaracetam for Multiple Dose |
5215 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study |
12 | — |
| SECONDARY Time to Reach Maximum Concentration (Tmax) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose |
1.000; 3.000; 9.000; 6.000 | — |
| SECONDARY Terminal Elimination Half-life (t1/2) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose |
9.628; 10.40; 10.24; 12.38 | — |
| SECONDARY Rate Constant of Elimination (λz) of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose |
0.07370; 0.06866; 0.06847; 0.05614 | — |
| SECONDARY Mean Residence Time (MRT) of Brivaracetam in Plasma for Single Dose |
13.02 | — |
| SECONDARY 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 |
36000; 2567; 2530; 878.2 | — |
| SECONDARY Apparent Total Body Clearance (CL/F) of Brivaracetam in Plasma for Single Dose |
2.777 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) of Brivaracetam in Plasma for Single Dose |
37.69 | — |
| SECONDARY Cmax of Ucb-42145, Ucb-100406-1 and ucb107092-1 for Single Dose |
193.3; 93.16; 43.18 | — |
| SECONDARY AUC (0-t) of Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Single Dose |
2503; 2423; 799.2 | — |
| SECONDARY Tmax of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose |
0.5000; 3.000; 1.500; 4.000 | — |
| SECONDARY t1/2 of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose |
10.25; 10.15; 9.645; 14.85 | — |
| SECONDARY λz of Brivaracetam, Ucb-42145, Ucb-100406-1 and ucb107092-1 in Plasma for Multiple Dose |
0.06860; 0.06984; 0.07228; 0.04721 | — |
| SECONDARY Minimum Plasma Concentration at Steady State (Cmin,ss) of Brivaracetam in Plasma for Multiple Dose |
1696 | — |
| SECONDARY Average Plasma Concentration at Steady State (Cav,ss) of Brivaracetam in Plasma for Multiple Dose |
3064 | — |
| SECONDARY Apparent Total Body Clearance at Steady State (CLss/F) of Brivaracetam in Plasma for Multiple Dose |
2.720 | — |
| SECONDARY Vz/F of Brivaracetam in Plasma for Multiple Dose |
39.65 | — |
| SECONDARY Cmax,ss of Ucb-42145, Ucb-100406-1, and ucb107092-1 in Plasma for Multiple Dose |
357.9; 264.8; 88.53 | — |
| SECONDARY 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 |
2644; 2844; 867.1 | — |
| SECONDARY Peak Trough Fluctuation (PTF) of Brivaracetam in Steady-state for Multiple Dose |
1.131 | — |
| SECONDARY Accumulation Ratio Calculated From AUC at Steady State and AUC After Single Dose (RAUC) of Brivaracetam for Multiple Dose |
1.677 | — |
| SECONDARY Accumulation Ratio Calculated From Cmax at Steady State and Cmax After Single Dose (Rmax) of Brivaracetam for Multiple Dose |
1.564 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04882540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.