F901318- Phase 1 Safety tolerability & PK study
Research type
Research Study
Full title
A PHASE I, OPEN LABEL STUDY IN HEALTHY SUBJECTS TO EVALUATE THE SAFETY,TOLERABILITY AND PHARMACOKINETICS OF VARYING ORAL DOSING REGIMENS FOR F901318
IRAS ID
233248
Contact name
Jim Bush
Contact email
Sponsor organisation
F2G Ltd
Eudract number
2017-003314-52
Duration of Study in the UK
0 years, 4 months, 7 days
Research summary
F901318 is a new antifungal agent being developed as a treatment for invasive and rare fungal infections.
The study will be an open label, randomised, parallel group evaluation of different dosing schedules. The aims are to evaluate safety, tolerability and pharmacokinetics of F901318 (how quickly the drug gets into and is removed from the blood stream). The effect of food on the pharmacokinetics of F901318 is also being determined, together with the effect of F901318 on the pharmacokinetics of midazolam, in order to assess the effect of F901318 on cytochrome P450 3A4 activity (an enzyme responsible for breaking down drugs such as midazolam in humans).
Up to 60 male and female subjects will be included in 4 cohorts of 12 subjects and 1 optional cohort of 8 to 12 subjects. The optional cohort will only be conducted if target plasma concentrations are not achieved in the first cohort.
In all cohorts, subjects will be admitted to the clinic the day before the first dosing occasion and will leave the clinic no earlier than 24 hours after the last dosing occasion.
Cohorts A1, A2 (optional), B1 and B2 will receive multiple oral doses of F901318 (3 or 4 times per day) for 10 days (A1 and A2) or 28 days (B1 and B2). In Cohort B2 subjects will also receive a single oral dose of midazolam on Days -1 and 10. Subjects in Cohorts A1/A2 will return for 1 non-residential follow-up, and those in Cohorts B1/B2 will attend 4 non-residential follow up visits.
In Cohort C subjects will receive 2 single oral doses of F901318 separated by at least 10 days. One dose will be administered fasted and the other after a high fat breakfast. In each treatment period, subjects will attend 3 to 4 non-residential follow up visits.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0485
Date of REC Opinion
2 Oct 2017
REC opinion
Further Information Favourable Opinion