Effect of ASP2151 on the blood levels of montelukast; version 1
Research type
Research Study
Full title
A single-centre, open-label, randomised, crossover, drug-drug interaction study in healthy men to investigate the effect of a single dose of ASP2151 on the pharmacokinetics of montelukast (HMR code: 14-021)
IRAS ID
164713
Contact name
Adeep Puri
Contact email
Eudract number
2014-003955-73
Clinicaltrials.gov Identifier
NCT 02321748
Duration of Study in the UK
1 years, 0 months, 0 days
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).
Many medicines are broken down in 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 CYP2C8. Montelukast, a medicine used to treat allergic diseases (like asthma), is broken down in the liver by CYP2C8. In this study, volunteers will take a single dose of montelukast, with and without ASP2151. We’ll compare blood levels of montelukast after each dose, to find out how ASP2151 affects breakdown of medicines by CYP2C8. We’ll also find out if taking the 2 medicines together causes any important side effects.
24 healthy men, aged 18–45 years, will each have 2 study sessions – in one session, they’ll take 10 mg montelukast alone, and in the other session, they’ll take 10 mg montelukast with 400 mg ASP2151.
Participants will take up to 10 weeks to finish the study. They’ll stay on the ward for 4 days and 4 nights in each study session (12 days and nights in total), and make 4 outpatient visits.
A pharmaceutical company (Maruho Europe Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
Scotland A REC
REC reference
14/SS/1056
Date of REC Opinion
28 Oct 2014
REC opinion
Favourable Opinion