A PK, Safety and Tolerability Study in IV/Oral Doses of Olorofim
Research type
Research Study
Full title
A PHASE I, OPEN-LABEL, RANDOMISED, BIOPHARMACEUTICS STUDY IN HEALTHY SUBJECTS TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF SINGLE DOSES OF IV AND ORAL FORMULATIONS OF OLOROFIM
IRAS ID
270996
Contact name
Jim Bush
Contact email
Sponsor organisation
F2G
Eudract number
2018-001112-30
Clinicaltrials.gov Identifier
19/NE/0268 , REC reference
Duration of Study in the UK
0 years, 2 months, 11 days
Research summary
F901318, also known as Olorofim, is currently being developed as an IV and oral treatment for invasive fungal infection (IFI) due to olorofim susceptible mould fungi in patients with limited treatment options. Fungal infections are an increasing problem, especially in people with a weak immune system which reduces their ability to fight against infection and disease. This includes people who have had organ or bone marrow transplants, have received chemotherapy to treat cancer, or who have AIDS.
The aims of this study are to evaluate safety, tolerability, pharmacokinetics (how quickly the drug gets into the blood stream and how quickly it is removed from the body), and also to study the effect of food on the pharmacokinetics on 30 mg oral tablets of F901318 in healthy subjects.
In this open-label study 12 subjects will be studied in two cohorts of 6 (Cohorts A and B), with at least 1 female in each cohort.
Subjects will participate in 3 treatment periods and in each treatment period they will reside at the Clinical Research Unit from Day -1 (the day before dosing) to Day 3 (48 hours post-dose), returning for short non-residential visits on Days 4, 5 and 6 (72, 96 and 120 h respectively). There will be at least 10 days between dosing with a short non-residential follow-up visit 10 days after the final dose of olorofim.
On the morning of Day 1 in each treatment period, and in accordance with a master randomisation schedule, subjects will receive either:
• A single 2 h IV infusion of 150 mg olorofim, with the infusion starting after an overnight fast.
• A single oral dose of 150 mg olorofim, administered as 30 mg tablets after an overnight fast.
• A single oral dose of 150 mg olorofim, administered as 30 mg tablets 30 minutes after starting a high-fat breakfast.REC name
North East - York Research Ethics Committee
REC reference
19/NE/0268
Date of REC Opinion
5 Nov 2019
REC opinion
Further Information Favourable Opinion