Oral delivery of semaglutide to the colon for improved absorption
Research type
Research Study
Full title
An exploratory pharmacoscintigraphic single centre, open-label, crossover study in healthy volunteers to evaluate novel oral modified release semaglutide tablets
IRAS ID
1006243
Contact name
Laura Gow
Contact email
Sponsor organisation
BDD Pharma Ltd
Eudract number
2022-002566-32
ISRCTN Number
ISRCTN60358675
Research summary
This study has been designed to investigate the in vivo gastrointestinal behavior and absorption of targeted release semaglutide tablets.\n\nThe following treatments will be dosed during this study:\nTreatment A: One radiolabelled Rybelsus ® 7mg semaglutide tablet \nTreatment B: Two radiolabelled 3.5mg semaglutide EC OralogiK tablets (designed to release in the proximal colon )\nTreatment C: Two radiolabelled 3.5mg semaglutide EC delayed release OralogiK tablets (designed to release in the mid small intestine).\n\nThe primary purpose of this study is to evaluate the performance of two early prototype targeted release semaglutide formulations using gamma scintigraphy to monitor their location in the gastrointestinal tract with time in the fasted state.\n\nThe study will be conducted in healthy male volunteers aged between 18 - 60 years old. There are no benefits to the subjects participating in the study.\n\nIn this study we will use scintigraphic imaging to confirm the site of release of the tablets in the gastrointestinal tract. To look at this parameter, we will add a small amount of radioactive materials to each tablet. Blood samples will also be taken at specific timepoints throughout each visit to asses the absorption of semaglutide in the blood.\n\nSubjects will attend the unit fasted and standardised meals will be provided at set times during the assessment visits. Subjects will be required to attend the study unit on up to five occasions.
REC name
London - Hampstead Research Ethics Committee
REC reference
22/LO/0596
Date of REC Opinion
13 Oct 2022
REC opinion
Further Information Favourable Opinion