Effect of ASP2151 on the blood levels of bupropion, version 1
Research type
Research Study
Full title
A single-centre, open-label study in healthy men to investigate the effect of repeated oral doses of ASP2151 on the pharmacokinetics of bupropion (HMR code: 14-025)
IRAS ID
167714
Contact name
Adeep Puri
Contact email
Eudract number
2014-004656-59
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
ASP2151 (the study medicine) is an experimental treatment for infection with some types of herpes virus. Herpes viruses cause conditions, such as cold sores, genital herpes, chickenpox and shingles. Once infected, the virus stays in the body for life. Some people show no signs of infection, but others have occasional or frequent outbreaks. We hope ASP2151 will improve the symptoms of outbreaks, and make them less frequent, by blocking substances that herpes viruses use to multiply themselves (the helicase primase complex).
Many medicines are broken down in the liver by substances called enzymes. Sometimes, when 2 medicines are taken together, it can affect how quickly enzymes break down one or both medicines, and how long it takes the body to get rid of them. We're doing this study to find out if ASP2151 affects an enzyme called CYP2B6. Bupropion is an existing medicine that’s broken down in the liver by CYP2B6. In this study, participants will take single doses of bupropion, with and without ASP2151. We'll compare blood levels of bupropion after each dose, to find out how ASP2151 affects breakdown of medicines by CYP2B6. We'll also find out if taking the 2 medicines together causes any important side effects.
24 healthy men, aged 18-45 years, will take 10 daily doses of 400 mg ASP2151 and 4 single doses of bupropion. They’ll take a dose of bupropion 5 days before ASP2151 treatment, on the last day of ASP2151 treatment, and at 7 and 14 days after ASP2151 treatment.
Participants will take up to 10½ weeks to finish the study. They'll have 3 ward stays (29 days and nights in total), and make 3 outpatient visits.A pharmaceutical company (Maruho Europe Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/0002
Date of REC Opinion
22 Jan 2015
REC opinion
Favourable Opinion