Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics and Safety of Brivaracetam in Healthy Chinese Subjects
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Healthy Participants
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04882540
Start Date
May 19 2021
End Date
June 8 2021
Last Update
March 13 2023
Active Locations (1)
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1
Ep0101 101
Shanghai, Shanghai Municipality, China