The effect of erthromycin on the blood levels and safety of padsenovil
Research type
Research Study
Full title
An open-label, fixed-sequence study in healthy study participants to evaluate the effect of coadministered erythromycin on the pharmacokinetics and safety of padsevonil. (HMR code: 17-017)
IRAS ID
241735
Contact name
Adeep Puri
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2017-004694-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 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, which will prevent patients from having fits. \n\nThere are many treatments for epilepsy, but they don’t work in all patients, and some have troublesome side effects. Padsevonil works in a different way from current treatments. We hope it’ll work in patients who don’t benefit from other treatments. \n\nPadsevonil is broken down in the liver by substances called enzymes. Sometimes, when 2 medicines are taken together and are broken down by the same enzyme, it takes longer for the body to get rid of one or both of them. We’re doing this study, in healthy people, to find out if the body takes longer to get rid of padsevonil when it is taken with an antibiotic, called erythromycin, which is broken down by the same enzyme in the liver. We’ll measure blood and urine levels of padsevonil. We’ll also assess whether taking the medicines together causes any extra side effects.\n\nWe’ll recruit 28 healthy participants, aged 18–55. They’ll have 3 sessions. In Sessions 1 and 2, they’ll take daily doses of padsevonil for 5 days. In Session 3, they’ll take daily doses of erythromycin for 3 days, followed by daily doses of erythromycin and padsevonil together for 8 days, and then daily doses of erythromycin alone for 4 days.\n\nParticipants will take up to 7 weeks to finish the study; they’ll make 4 outpatient visits, and stay on the ward for 33 nights.\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
18/NI/0022
Date of REC Opinion
12 Mar 2018
REC opinion
Further Information Favourable Opinion