Comparing blood levels of UCB0942 in Japanese and Caucasian volunteers
Research type
Research Study
Full title
A single-centre, investigator/subject blind, placebo-controlled, single and multiple oral dose investigation of safety, tolerability, and pharmacokinetics of UCB0942 in healthy Japanese and Caucasian subjects (16-033)
IRAS ID
224611
Contact name
Adeep Puri
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2017-000385-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
The study medicine is an experimental treatment for epilepsy, a condition that causes fits (also known as seizures). Fits occur when there’s a sudden burst of electrical activity in the brain, which temporarily disrupts the way the brain normally works. We hope the study medicine will reduce abnormal electrical activity in the brain, and prevent patients from having fits. As the study medicine works in a different way from current treatments, we hope it’ll work in patients who don’t benefit from other treatments. \n\nIf this and future studies are successful, the study medicine may be useful for treating patients in many countries, including in Japan. First, we need to test it in healthy Japanese people, so we can compare the results across other ethnic groups. We’re doing this study in Japanese participants to compare blood levels of the study medicine in Japanese and Caucasian participants.\n\nWe’ll recruit 36 healthy Japanese and 12 healthy Caucasian participants, aged 20–55 years. There’ll be 4 groups: \n\n*Groups 1 and 2 (Japanese) will take a single dose of study medicine (50 and 100 mg dose, respectively). Participants will take up to 5 weeks to finish the study, make up to 2 outpatient visits, and stay on the ward for 3 nights. \n\n*Group 3 (Japanese) and 4 (Caucasian) will take a single dose of 200 mg study medicine. After a gap of up to 3 weeks, they’ll return to the study centre and take 100 mg, twice daily, for 3 days, and a single 100 mg dose the next day. Participants will take up to 8 weeks to finish the study, make up to 2 outpatient visits, and stay on the ward 9 nights.\n\nA pharmaceutical company (UCB Biopharma) is funding the study.\n\nThe study will take place at 1 centre in London.\n
REC name
HSC REC A
REC reference
17/NI/0049
Date of REC Opinion
30 Mar 2017
REC opinion
Favourable Opinion