Comparing blood levels of Lacosamide in Japanese volunteers, v1
Research type
Research Study
Full title
A Single-Center, Open-Label, Randomized, Single-Oral Dose, 2-Way Cross-Over Study To Investigate The Bioequivalence Between Lacosamide Tablet And Dry Syrup In Healthy Male Japanese Subjects (16-016)
IRAS ID
213244
Contact name
Jeremy Dennison
Contact email
Sponsor organisation
UCB Biopharma
Eudract number
2016-002462-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Fits (also known as seizures) occur when there’s a sudden burst of strong electrical activity in the brain, which temporarily disrupts the way the brain normally works. Lacosamide (the study medicine) is used to treat fits and works by reducing the abnormal electrical activity in the brain. The study medicine is currently available as tablets, which are convenient for people to take, but some people struggle to swallow them. So, we’ll test a syrup form of the study medicine for people who struggle to take tablets.\n\nWe’re doing this study to compare the tablet and syrup forms of the study medicine in Japanese people, so that we can make the syrup available in Japan. To do that, we’ll give up to 24 healthy Japanese volunteers, aged 20–55 years, 2 single doses of the study medicine: once as a tablet and once as syrup. \n\nParticipants will take about 7 weeks to finish the study. They’ll make 2 outpatient visits and stay on the ward for 2 study sessions; in each study session, they’ll stay for 4 nights in a row.\n\nA pharmaceutical company, UCB Biopharma, is funding the study.\n\nThe study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
16/NI/0183
Date of REC Opinion
21 Sep 2016
REC opinion
Favourable Opinion