Effect of ciclosporin 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 repeated oral doses of ciclosporin on the single-dose pharmacokinetics of ASP2151 in healthy men (HMR code: 14-015)
IRAS ID
162301
Contact name
Adeep Puri
Contact email
Eudract number
2014-002190-11
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 who have a weakened immune system. Some medicines work by weakening the body’s immune system (called immunosuppressants), so people taking immunosuppressants are more susceptible to herpes virus outbreaks. Ciclosporin is a commonly used immunosuppressant, so patients may need to take ASP2151 and ciclosporin, at the same time.
We aim to find out whether taking ciclosporin and ASP2151 together affects blood levels of ASP2151, and causes any important extra side-effects.
24 healthy men, aged 18–45 years, will each have 2 study sessions – in 1 session they’ll take 2 single doses of 400 mg ASP21512, and in the other session they’ll take 2 single doses of 1200 mg ASP2151. In both sessions they’ll also take 15 doses of 100 mg ciclosporin over 8 days.
Participants will take up to 14 weeks to finish the study. They’ll stay on the ward for 12 days and 11 nights in a row nights in each study session, and make up to 6 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
14/LO/1431
Date of REC Opinion
19 Sep 2014
REC opinion
Favourable Opinion