PK, Safety and Tolerability of Brivaracetam Muco-Adhesive Gels
Research type
Research Study
Full title
Open-Label, Single-Dose, Pilot Study to Compare the Pharmacokinetics, Safety, and Tolerability of Brivaracetam from a Range of Muco-Adhesive Gels and Orally-Dosed Solution in Healthy Volunteers
IRAS ID
243832
Contact name
Helene Kadima
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2018-000672-15
Duration of Study in the UK
0 years, 3 months, 24 days
Research summary
The Sponsor is developing a new formulation (recipe) of the already marketed medicine, brivaracetam (BRV). Brivaracetam is currently licensed for use in patients with partial-onset seizures with or without secondary generalization in epilepsy and is administered orally (tablet or solution) or intravenously (bolus or infusion).\n\nThe aim of this study is to develop a suitable buccal formulation (administered into the oral cavity [inner cheek or under the lip]) to take forward into clinical efficacy assessments in patients who suffer from epilepsy with acute repetitive seizures.\n\nThe study will consist of 2 groups (Group A and Group B), each involving up to 16 healthy male and female volunteers. In Group A, variants of gel formulations, in addition to 1 oral solution formulation (reference), will be tested over 6 periods. The precise intra-oral location of dose administration will also be investigated in one chosen gel formulation (based on data gathered from previous doses in Group A) as this will be given both inside the cheek and under the front lip. Once dosed, volunteers will remain in the clinical unit for 2 days for blood samples to be taken and safety assessments performed. \n\nIn group B a formulation selected from Group A will be tested over 4 periods. The formulation will be dosed at two dose levels to assess dose proportionality. The polymer composition will be altered in 1 period and dosing without massage will also be investigated. Once dosed, volunteers will remain in the clinical unit for 2 days for blood samples to be taken and safety assessments performed.\n\nThroughout the study inspections of the volunteer’s mouths will be made and volunteers will be asked about the taste of the new formulations in palatability questionnaires.
REC name
Wales REC 2
REC reference
18/WA/0340
Date of REC Opinion
19 Oct 2018
REC opinion
Further Information Favourable Opinion