A MAD Study of F901318 in Male and Female Subjects
Research type
Research Study
Full title
F901318 - A PHASE I, DOUBLE-BLIND, PLACEBO CONTROLLED, MULTIPLE\nASCENDING ORAL DOSE, SAFETY, TOLERABILITY AND PHARMACOKINETIC\nSTUDY IN HEALTHY MALE AND FEMALE SUBJECTS
IRAS ID
203317
Contact name
Annelize Koch
Contact email
Sponsor organisation
F2G limited
Eudract number
2016-000314-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 11 days
Research summary
The purpose of this study is to investigate a drug called F901318 and to assess the safety and tolerability of this drug when given once or twice daily for 10 consecutive days. The study will also look at how quickly F901318 enters the bloodstream, is distributed in the blood, broken down and disposed of by the body. The way in which the body deals with the drug is defined as the drugs Pharmacokinetic characteristics. \n\nF901318 is being developed for the treatment of human mycoses, in particular Invasive Aspergillosis. Which is a potentially lethal fungal infection, and those people who are immunocompromised are at a higher risk. \n\nThis study will be carried out in 3 cohorts of 8 healthy male and female volunteers (24 total).\n
REC name
Wales REC 1
REC reference
16/WA/0094
Date of REC Opinion
23 Apr 2016
REC opinion
Further Information Favourable Opinion