Effect of F901318 on blood levels of midazolam, v1
Research type
Research Study
Full title
An open label study in healthy volunteers to evaluate the potential for cytochrome P450 3A4 inhibition by F901318 using oral midazolam as a probe (HMR code: 15-029)
IRAS ID
195001
Contact name
Frans van den Berg
Contact email
Sponsor organisation
F2G Ltd
Eudract number
2015-001816-37
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
F901318 is an experimental new treatment for a serious fungal infection, invasive aspergillosis, which occurs when fungal moulds infect body organs, usually the lungs. In healthy people, such infections are rare, as the immune system stops the infection. But patients who have a weakened immune system, such as AIDS or transplant patients, are more at risk of developing serious fungal infections.
Most medicines available to treat invasive aspergillosis have troublesome side effects or stop working before the infection is fully treated. F901318 works in a different way to existing medicines, so we hope it will work better, and have fewer side effects.
Like many other medicines, F901318 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 the medicines, and how quickly the body gets rid of them. We're doing this study to find out if F901318 affects an enzyme called CYP3A4. To test that, we’ll give participants an existing medicine, called midazolam, that’s broken down by CYP3A4. We'll compare blood levels of midazolam when taken alone and together with F901318. We'll also assess if taking the medicines together causes any important extra side effects, and the blood levels of F901318.
We’ll give 20 healthy men, aged 18–45 years, 5 daily doses of F901318 (by infusion into a vein), and 2 single doses of midazolam (by mouth). Participants will take one dose of midazolam alone and one dose together with the last dose of F901318:
Participants will take up to 5 weeks to finish the study. They’ll make 3 outpatient visits, and stay on the ward for 8 nights.
A pharmaceutical company (F2G 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/2035
Date of REC Opinion
17 Dec 2015
REC opinion
Favourable Opinion