Effect of food and itraconazole on blood levels and safety of UCB0599
Research type
Research Study
Full title
A Phase I, open-label study to assess the potential effect of food and co-administered itraconazole on the disposition of UCB0599 and its metabolites in healthy study participants. HMR code (18-025)
IRAS ID
265935
Contact name
Lisa Slade
Contact email
Sponsor organisation
UCB Biopharma SPRL
Eudract number
2000-000379-17
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
UCB0599 (the study medicine) is an experimental new medicine for treating Parkinson’s disease. Parkinson’s disease is caused by a loss of a type of cells (neurons) in the brain, which leads to parts of the brain becoming damaged over time. We don’t know exactly what causes the loss of neurons, but it’s thought to be associated with the misfolding and build-up of a substance (protein) in the brain called alpha-synuclein (ASYN). We hope that the study medicine will prevent the misfolding and build-up of ASYN and slow disease progression.\nThe study medicine is broken down in the liver by substances called enzymes. Sometimes, when you take 2 medicines together, it can affect how quickly enzymes break down one or both of them, and how long it takes the body to get rid of them. We’re doing this study to find out whether taking another medicine, called itraconazole, affects the way the body handles the study medicine. We also aim to find out whether food affects the blood levels of the study medicine, and whether there are any extra side effects when the study medicine is taken together with food or itraconazole. \nWe’ll recruit 22 healthy participants, aged 18–55. They’ll have 3 sessions:\n* Sessions 1 and 2: they’ll take a single dose of study medicine in each session, either after fasting or after a high-fat breakfast.\n* Session 3: they’ll take daily doses of itraconazole for 8 days (Day 15–22) and a single dose of study medicine on Day 18.\n\nParticipants will take up to 4 weeks to finish the study; they’ll make 5 outpatient visits, and stay on the ward for 15 nights in total.\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
19/NI/0169
Date of REC Opinion
4 Oct 2019
REC opinion
Favourable Opinion