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

NCT04882540 | Completed Phase 1 Results

• 1 other identifier: EP0101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Epilepsy; Healthy participants; Phase 1; Brivaracetam

Outcome Measures

Primary Outcomes (7)

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

  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

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  Day 1: Predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, and 72 hours postdose

Study Arms (1)

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.

Drug: brivaracetam

Interventions

brivaracetam DRUG

* Pharmaceutical form: Film-coated tablets * Concentration: 100 mg tablets * Route of administration: Oral use

Also known as: Briviact

brivaracetam

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (1)

Ep0101 101

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: May 19, 2021
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: March 13, 2023
• Results First Posted: March 13, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)