Thorough QT study of padsevonil
Research type
Research Study
Full title
A single-center, randomized, placebo-controlled, 3 treatment period crossover study to assess the effect of padsevonil on cardiac repolarization (QTc interval)(using moxifloxacin as a positive control)in healthy study participants (19-010)
IRAS ID
271101
Contact name
Gregory Lelij
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2019-002797-31
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Padsevonil is an experimental treatment for epilepsy, a condition that causes fits (or 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 padsevonil will reduce abnormal electrical activity in the brain, and prevent patients from having fits. We hope it’ll work in patients who don’t benefit from other treatments.
When developing new medicines, it’s important to test for any effect on the heart. We do that using electrocardiograms (ECGs), which painlessly record the electrical activity of the heart. The main aim of this study is to find out if repeated doses of padsevonil have any effect on ECGs.
To make sure we can detect any effects on ECGs that padsevonil might cause, we’ll give participants a single dose of moxifloxacin – an antibiotic that causes small and short-lived changes in ECGs. Moxifloxacin is a marketed medicine, which can be prescribed by doctors.
We’ll recruit 54 healthy men and women, aged 18–55 years. Each participant will have 3 study sessions. In each study session, they’ll take twice-daily doses for 11 days, as follows: padsevonil in 1 session; dummy medicine in 1 session; and a dummy medicine, with a single dose of moxifloxacin (on Day 8 only) in 1 session. Padsevonil and the dummy medicine look the same, so neither the participants nor we will know which one they’re taking. Moxifloxacin looks different, so we’ll know when they’re taking it.
Participants will take up to 9.5 weeks to finish the study, make 2 outpatient visits, and stay on the ward for 42 nights over 3 sessions.
A pharmaceutical company (UCB Biopharma) is funding the study.
The study will take place at 1 centre in London.
REC name
HSC REC A
REC reference
19/NI/0166
Date of REC Opinion
18 Oct 2019
REC opinion
Further Information Favourable Opinion