Effect of ritonavir on the blood levels of ASP2151; version 1
Research type
Research Study
Full title
A single-centre, open-label, randomised, crossover, drug-drug interaction study to investigate the effect of a single oral dose of ritonavir on the single dose pharmacokinetics of ASP2151 in healthy men (HMR code: 14-014)
IRAS ID
161307
Contact name
Adeep Puri
Contact email
Sponsor organisation
Maruho Europe Ltd
Eudract number
2014-002174-37
Research summary
ASP2151 (the study medicine) is an experimental medicine for treating infection with some types of herpes virus. Different herpes viruses cause different 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).
Outbreaks are more common in people infected with HIV (the AIDS virus). So HIV patients may need treatment with ASP2151. HIV patients also take other medicines, such as ritonavir, to treat the HIV infection, so patients may need to take ASP2151 and ritonavir at the same time.
We aim to find out whether taking ritonavir and ASP2151 together affects blood levels of ASP2151, and causes any important extra side-effects.
We’ll give 48 healthy men, aged 18–45 years, 2 single doses of ASP2151. Each participant will have 2 study sessions – in 1 session, they’ll take either 400 mg or 1200 mg ASP2151, and in the other, they’ll take the same dose of ASP2151 with 600 mg ritonavir.
Participants will take up to 11 weeks to finish the study. They’ll stay on the ward for 3 nights in each study session, and make up to 8 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 - Brent Research Ethics Committee
REC reference
14/LO/1213
Date of REC Opinion
8 Aug 2014
REC opinion
Favourable Opinion