A Phase I study to show how different formulations of HLD400 perform
Research type
Research Study
Full title
A Two-Way Sequential, Non-Randomised, Open-Label Study Designed to Evaluate the In Vivo Performance of Delayed and Extended Release Prototype Formulations of HLD400 in the Fasted State in Healthy Subjects
IRAS ID
214607
Contact name
Bev Incledon
Contact email
Sponsor organisation
Ironshore Pharmaceuticals & Development, Inc.
Eudract number
2016-003506-14
Duration of Study in the UK
0 years, 1 months, 18 days
Research summary
The study will compare two different formulations (recipes) that use a special technology to delay and extend the release of mesalazine throughout the colon and rectum. The test medicine will be administered as small film-coated beads sprinkled onto chocolate mousse. In order to detect where the drug is being released, the test medicine will be radiolabelled. ‘Radiolabelled’ means that the study drug has a radioactive component so its movement can be tracked through the digestive system (gut). \n\nGamma scintigraphy will be used to detect where the drug is released. Gamma scintigraphy is a method whereby pictures of the test medicine’s route through the digestive system are taken using a special camera which detects the radiolabelled drug. This will allow researchers to pinpoint the location at which the test medicine is absorbed by the body.\n\nThe study will enrol 12 healthy male and female subjects who will receive 250 mg of the test medicine on 2 separate occasions. The test medicine will be given with water containing a small amount of radioactivity. There will be a minimum washout of 7 days between each administration of the test medicine. After subjects take the test medicine, blood and urine samples and pictures of the digestive system will be taken at regular intervals up to 48 hours post-dose.\n\nThe purpose of testing the two formulations is to determine the location of release in the colon, and to see if the medicine can be developed to release mesalazine along the entirety (whole) of the colon.\n
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0339
Date of REC Opinion
17 Jul 2017
REC opinion
Favourable Opinion