The effect of padsevonil on the blood levels of oral contraceptives
Research type
Research Study
Full title
An open-label, randomized two-way crossover study to investigate the potential pharmacokinetic interaction of padsevonil with oral contraceptives in healthy female participants. HMR code: 19-009
IRAS ID
271102
Contact name
Gregory Lelij
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2019-002194-54
Duration of Study in the UK
0 years, 9 months, 21 days
Research summary
Padsevonil (PSL) 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.
There 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.
Like many other medicines, padsevonil 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 to find out whether padsevonil affects the breakdown of an oral contraceptive pill, called Microgynon 30®(or “microgynon”), that is also broken down by enzymes in the liver. We’ll measure blood levels of padsevonil and microgynon. We’ll also assess whether taking the medicines together causes any extra side effects.
We’ll recruit up to 40 healthy women, aged 18 years or older, who have not been through the menopause. Each participant will have 2 sessions. In one session, they’ll take a single oral dose of microgynon. In the other session, they’ll take repeated doses of padsevonil, twice-daily for 20 days, and a single oral dose of microgynon with padsevonil on Day 13.
Participants will take about 9 weeks to finish the study. They’ll make up to 2 outpatient visits, and stay on the ward for 23 nights over 2 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/0167
Date of REC Opinion
22 Oct 2019
REC opinion
Further Information Favourable Opinion