Phase I study to compare the effect of food on the test tablet
Research type
Research Study
Full title
A Two-Period, Randomised, Crossover Study Designed to Evaluate the In Vivo Performance of a Modified Release Formulation of Alicaforsen in Healthy Male Subjects in the Fed and Fasted State
IRAS ID
227388
Contact name
Chris Dunk
Contact email
Sponsor organisation
Atlantic Pharmaceuticals Ltd
Eudract number
2017-001913-98
Duration of Study in the UK
0 years, 1 months, 14 days
Research summary
The Sponsor is developing a tablet form of a new drug for the treatment of diseases caused by the actions of our own immune system (autoimmune diseases) such as Crohn’s disease, Ulcerative colitis, Psoriasis and Rheumatoid arthritis.
The purpose of this study is to identify where in the digestive system the tablet formulation breaks down and releases the test medicine after it is swallowed and to see whether being fed or fasted affects this. The study will evaluate where in the digestive system the test medicine is released from the tablet in the presence of food compared to the absence of food. The study drug will contain a radiolabelled component. ‘Radiolabelled’ means that the study drugs have a radioactive component which helps researchers to track the drugs as they move through and out of the body.
This is a 2 part study, involving up to 16 healthy male subjects aged 18 to 65 years. It is 2-way cross-over study, which means that each group will have the same test medicine under different conditions (fasted versus fed) in turn. Subjects will participate in both parts and will receive the test medicine by mouth on two occasions. During one of the study visits, subjects will be dosed after a high fat breakfast and the other following an overnight fast.
Gamma scintigraphic images will be taken at selected time points up to 24 hours post-dose. Gamma scintigraphy is a method whereby pictures of the test medicine’s route through the gut are taken using a special camera which detects the radiolabelled component in the drug. Blood and faecal samples will also be collected.
REC name
London - Westminster Research Ethics Committee
REC reference
17/LO/1087
Date of REC Opinion
8 Aug 2017
REC opinion
Further Information Favourable Opinion