The effect of itraconazole and rifampicin on blood levels of olorofim
Research type
Research Study
Full title
A Phase I, Open Label Study in Healthy Subjects to Evaluate the Effect of Itraconazole and Rifampicin upon the Pharmacokinetics of a Single Oral dose of Olorofim. (18-013)
IRAS ID
257645
Contact name
Frans van den Berg
Contact email
Sponsor organisation
F2G Ltd
Eudract number
2018-004345-16
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
The study medicine (olorofim) is an experimental treatment for serious fungal infections, such as 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 cancer, AIDS or transplant patients, are more at risk of developing serious fungal infections. We hope that olorofim will work by blocking a substance that fungal moulds use to multiply.
Patients with serious fungal infections will often be taking other medicines. Sometimes, taking 2 medicines together can affect how long the body takes to get rid of one or both of them. We’re doing this study, to find out whether taking olorofim with itraconazole (another antifungal treatment) or rifampicin (an antibiotic used to treat tuberculosis and other bacterial infections) affects the way the body handles olorofim. If olorofim is removed more slowly when taken with itraconazole, or more quickly when taken with rifampicin, there may be more side effects or less response to olorofim.
24 healthy men and women, aged 18–55, in 2 groups of 12 (Groups A and B) will have 1 study session. They’ll take a single dose of olorofim on its own, then they’ll take itraconazole (Group A) or rifampicin (Group B) each morning for 10 days. On the morning of the sixth day of taking itraconazole, or rifampicin, they’ll take another dose of olorofim.
In the 4 weeks before starting the study, participants will have a screening visit. Eligible participants will take up to about 3 weeks to finish the study. They’ll make up to 3 outpatient visits, and stay on the ward for 16 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
19/LO/1471
Date of REC Opinion
14 Nov 2019
REC opinion
Further Information Favourable Opinion