A phase I,single oral dose study of F901318 in healthy male volunteers
Research type
Research Study
Full title
F901318 - A PHASE I, DOUBLE-BLIND, PLACEBO CONTROLLED, SINGLE ASCENDING ORAL DOSE, SAFETY, TOLERABILITY AND PHARMACOKINETIC STUDY IN HEALTHY MALE SUBJECTS
IRAS ID
179277
Contact name
Girish Sharma
Contact email
Sponsor organisation
F2G limited
Eudract number
2015-000562-61
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
This study is looking at a drug called F901318 which is a type of antifungal medicine. The purpose of this study is to look at the safety and tolerability of F901318 in healthy male subjects and to look at the pharmacokinetic profile of F901318 following oral administration of an antifungal agent for the treatment of invasive aspergillosis in healthy subjects.
F901318 is a novel antifungal agent that exhibits a new mechanism of action for the treatment of human mycoses.
F901318 is specific for the fungal version of DHODH ((dihydroorotate dehydrogenase) and does not interact with the human enzyme.
F901318 is active by both oral and intravenous routes of administration in nonclinical efficacy studies. It is hoped that F901318 will extend the treatment options for Invasive Aspergillosis (IA) infections as a potential monotherapy or as a combined therapy with other antifungal agents with different antifungal modes of action.
The population who are eligible to take part in the study are healthy males aged between 18 and 45 years and with a body weight of 60-100 kg inclusive, as identified by screening tests at Simbec.
The study will consist of a single treatment period (running from Day 1 to 120 hours after dosing).REC name
Wales REC 1
REC reference
15/WA/0345
Date of REC Opinion
5 Nov 2015
REC opinion
Further Information Favourable Opinion