PK Evaluation of F901318 IR tablet in healthy volunteers (QCL117738)
Research type
Research Study
Full title
F901318 - A Two Part Study Designed To Evaluate the Single and Multiple Dose Pharmacokinetics of an Immediate Release Tablet Formulation of F901318 Compared with the Spray Dried Dispersion Reference Product in Healthy Male and Female Subjects
IRAS ID
206581
Contact name
Anthony Kennedy
Contact email
Sponsor organisation
F2G limited
Eudract number
2016-001136-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 3 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 try to measure the amount of F901318 that reaches the circulation when given as an immediate release tablet compared to when it is given as a liquid suspension. It will also investigate the effect of food on the amount of F901318 from the tablet that reaches the circulation in the fed and fasted state as well as the effect of the body on the study drug when it is given as a tablet once or twice daily.
The study will consist of 2 parts involving up to 20 healthy male and female subjects.
Part 1 will enrol 10 subjects and is further split into Parts 1A and 1B. In Part 1A of the study subjects will receive 360 mg of F901318 in a tablet formulation and 360 mg of F901318 in a suspension liquid formulation. There will be a minimum washout of 10 days between doses. Following Part 1A there will be a period of interim analysis to decide whether the dose of F901318 given as the tablet should be altered.
In Part 1B the selected dose of the F901318 immediate release tablet will be administered to subjects in the fed and fasted state in a randomised fashion. There will be a minimum washout of 10 days between doses provided to the volunteers.
Ten healthy male and female subjects will be enrolled into Part 2 where therapeutic doses of the F901318 immediate release tablet will be administered. Eight of the enrolled subjects will receive the active compound and two will receive the placebo.
REC name
Wales REC 1
REC reference
16/WA/0152
Date of REC Opinion
9 Jun 2016
REC opinion
Favourable Opinion