Study to evaluate PK of PRX167700 in fed and fasting state (QCL117933)
Research type
Research Study
Full title
An Open-Label, 3 Period, Randomised Crossover Study in Healthy Subjects to Evaluate the Pharmacokinetics of PRX167700H Immediate-Release Tablets Administered in the Fed and Fasting State and PRX167700H Immediate-Release Capsules Administered in the Fed State
IRAS ID
216869
Contact name
Maeve Duffy
Contact email
Sponsor organisation
Proximagen Limited
Eudract number
2016-004077-41
Duration of Study in the UK
0 years, 1 months, 4 days
Research summary
The Sponsor is developing the study drug, PRX167700H, for the potential treatment of long term inflammatory diseases.\n\nThe study will try to identify the effect of food on the pharmacokinetics (PK) of the study drug after being taken by mouth. PK is the impact of the body on the drug.\n\nThe study will consist of 3 study periods involving 36 healthy male and female subjects with up to 8 additional replacement subjects. In each Period, subjects will receive a total dose of either 400 mg study drug as a capsule or tablet following a standardised high fat breakfast or 400mg study drug as a tablet after an overnight fast. Samples of blood will be taken throughout the study to look at the concentrations of the drug in the body. \n
REC name
HSC REC B
REC reference
16/NI/0230
Date of REC Opinion
16 Nov 2016
REC opinion
Favourable Opinion