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

NCT ID: NCT04882540

Last Updated: 2023-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2021-06-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

brivaracetam

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.

Group Type: EXPERIMENTAL

brivaracetam

Intervention Type: DRUG

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

Interventions

brivaracetam

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

Intervention Type: DRUG

Other Intervention Names

Briviact

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Ep0101 101

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

EP0101

Identifier Type: -

Identifier Source: org_study_id