Scintigraphic evaluation of duodenal drug delivery formulations
Research type
Research Study
Full title
A proof-of-concept, open-label, two-arm scintigraphic crossover study in healthy adult volunteers to investigate the in vivo performance of two novel orally administered duodenal targeted drug-delivery formulations.
IRAS ID
366901
Contact name
Carol Thomson
Contact email
Sponsor organisation
BDD Pharma Ltd
Duration of Study in the UK
0 years, 2 months, 29 days
Research summary
This study is designed to assess the in vivo release and gastrointestinal performance of two drug delivery formulations containing a novel technology and designed to release in the first part of the small bowel (duodenum) after oral ingestion.
The tablets will be radiolabelled, and the study will evaluate the performance of the technology using scintigraphic parameters.
Prior to being dosed with the study treatments, participants will be administered a radiolabelled liquid to allow researchers to visualise their individual gastrointestinal tract anatomy.
The following formulations are being dosed throughout the study:
• Treatment A: One radiolabelled placebo P1 (Prototype 1) tablet
• Treatment B: One radiolabelled placebo P2 (Prototype 2) tabletBoth treatments and the liquid will be radiolabelled to contain a total dose of approximately 4 MBq 99mTc-DTPA each at time of dosing.
The primary purpose of the study is to investigate and compare the gastric emptying behaviour and time and site of release of the two formulations in a fasted state.
This single centre study will be conducted in up to 8 adult male and female healthy volunteers, aged 18 years or over.
In this study we will use scintigraphic imaging to visualise the gastric emptying of each treatment (when they leave the stomach) and confirm the time and site of radiolabel release in the gastrointestinal tract.
Participants will be required to attend the study site on up to five occasions with their participation in the study lasting between 3 and 7 weeks.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
26/SW/0006
Date of REC Opinion
28 Jan 2026
REC opinion
Favourable Opinion