A Study designed to test the in vivo Performance of IW-3718(QCL117541)
Research type
Research Study
Full title
A Single Centre, Open-Label, Randomised, Single Dose, 3-Way Scintigraphy Study in Healthy Subjects with 3 Periods, Each with a Different Breakfast Composition Designed to Evaluate the in vivo Performance of IW-3718 Compared with Immediate Release Colesevelam in the Fed State
IRAS ID
216442
Contact name
Meghan Bratton
Contact email
Sponsor organisation
Ironwood Pharmaceuticals Inc
Eudract number
2016-003977-17
Duration of Study in the UK
0 years, 1 months, 18 days
Research summary
The Sponsor is developing the test medicine, IW-3718 (colesevelam), for the potential treatment of gastro-oesophageal reflux disease (GERD). GERD is caused by a build-up of bile acids in the stomach and intestines. Bile acids play an important role in digesting food; however, if there is too much present for too long, it can lead to GERD. GERD patients suffer from heartburn and regurgitation (feeling of acid backing up into the throat. Colesevelam is a substance which soaks up bile acids in the stomach and intestines.
The purpose of the study is to compare the effect of food on the way the test medicine IW-3718 (colesevelam), and a marketed immediate release (IR) colesevelam medicine, work in the stomach and intestines. Both IW-3718 and IR colesevelam 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.
The Sponsor is developing IW-3718 in a special way, it is designed to stay in the stomach for longer than IR colesevelam, so it can soak up the bile acids in the place that appears to be important to prevent GERD.
The study will consist of 3 periods involving up to 18 healthy male and female subjects. Subjects will receive 500 mg of radiolabelled IW-3718 (study medicine), 625 mg of radiolabelled IR colesevelam and 1 of 3 different breakfasts in each period. 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 urine samples will also be collected
REC name
Wales REC 1
REC reference
16/WA/0347
Date of REC Opinion
3 Jan 2017
REC opinion
Further Information Favourable Opinion