PK study of Brivaracetam to compare OTF & Oral Soln.formulations in HV
Research type
Research Study
Full title
Open Label, Single Dose, Sequential Design, Pilot Study to compare the Pharmacokinetics, Safety and Tolerability of Brivaracetam from a range of Oral Thin Films and Orally Dosed Solution in Healthy Study Participants
IRAS ID
249656
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
UCB
Eudract number
2018-001753-27
Duration of Study in the UK
0 years, 2 months, 12 days
Research summary
This is an open-label, single-dose, sequential design, pilot study to compare the pharmacokinetics, palatability, safety, and tolerability of brivaracetam from a range of oral thin films (OTF) and the orally-dosed solution in healthy male and female subjects, at a single clinical centre.\n\nThe study design allows for a total of five treatment periods. Subjects will receive a single dose of study drug during each treatment period. It is planned for subjects to receive the OTF formulations during Treatment periods 1, 2, 4 and 5, and the oral solution during Treatment period 3. Each dose will be separated from the next by a wash-out period of at least 7 days. In addition, the study comprises a screening visit and a final follow-up visit. The planned dose of 100 mg in this study is expected to be well tolerated based on the safety profile of brivaracetam obtained from previous studies.\n\nBrivaracetam is being developed by the sponsor as treatment of acute repetitive seizures (ARS) in adult patients with epilepsy. This is not a first-in-human study. This means the study drug studied in this research project has been given to humans before. The drug has already been approved for marketing in several countries including the European Union, United States, Canada, Australia, Mexico, Turkey and Russia. The study drug is thought to work on specific proteins in the brain to bring about anticonvulsant effects.\n\nThe aim of this clinical trial is to develop an OTF formulation of brivaracetam which is suitable for administration into the inner cheek of a patient. For this purpose, the pharmacokinetics, palatability, safety, and tolerability of different brivaracetam formulations will be investigated in this study. Pharmacokinetics (PK) refers to how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body). Palatability refers to the acceptability of taste of the study drug. The study will also see how safe the study drug is after single doses of the different formulations were taken.\n
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/1182
Date of REC Opinion
21 Aug 2018
REC opinion
Further Information Favourable Opinion