ADME study of IV and oral 14C-F901318 in healthy males (QCL117739)
Research type
Research Study
Full title
An open label, single-dose, single-period study designed to assess the mass balance recovery, metabolite profile and metabolite identification of [14C]-F901318 administered via the intravenous and oral routes to healthy male subjects
IRAS ID
212764
Contact name
Anthony Kennedy
Contact email
Sponsor organisation
F2G limited
Eudract number
2016-003056-75
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 18 days
Research summary
The Sponsor is developing the study drug, F901318, for the potential treatment of fungal infections. A particular fungal infection that the drug could treat is called Invasive Aspergillosis which is an often fatal infection that occurs in patients
where the immune system is suppressed.The study will be conducted in healthy male subjects. It will look at how F901318 is handled and broken down in humans by using a small amount of radiolabelled F901318 ([14C]-F901318) given intravenously as a liquid or by mouth as a liquid.
The study will consist of 2 cohorts each enrolling five healthy male subjects. In cohort 1 each subject will receive a single intravenous administration of 300 mg [14C]-F901318. In cohort 2 each subject will receive a single oral administration of 400 mg [14C]-F901318. Subjects will remain resident in clinic until up to Day 15 and will return to the clinical unit for two further 24 hour residency periods on Day 21 and Day 28 if discharge criteria regarding mass balance recovery are not met. Blood, urine and faecal samples will be collected from each subject at regular time points post-dose.
REC name
Wales REC 1
REC reference
16/WA/0239
Date of REC Opinion
20 Sep 2016
REC opinion
Further Information Favourable Opinion