Duodenal delivery of a novel tablet formulation
Research type
Research Study
Full title
An exploratory two arm cross-over study to investigate the gastrointestinal behaviour of a novel tablet formulation designed for duodenal delivery using scintigraphic and radiological imaging in healthy volunteers
IRAS ID
322287
Contact name
Lyn Corry
Contact email
Sponsor organisation
Xerient Pharma Ltd
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
Research Summary
This study is designed to assess the in vivo release and gastrointestinal behaviour of a placebo tablet designed to cause a gel coating on the first part of the small bowel (duodenum) after oral ingestion.
The placebo tablets will be radiolabelled in addition to containing a radiopaque contrast agent and the study will evaluate the performance of the technology using both scintigraphy and radiological parameters.
The following treatments are being dosed throughout the study:
Part One
Treatment A: One radiolabelled enteric coated placebo tablet (approximately 7.2mm x 15mm in size)
Treatment B: Two or Three radiolabelled enteric coated placebo tablets (approximately 7.2mm x 15mm in size)
Treatment C: Four or Five radiolabelled enteric coated placebo tablets (approximately 7.2mm x 15mm in size)
Part Two:
Treatment D: Radiolabelled enteric coated placebo tablets. (Number of tablets, coating, and excipient ratio will be determined based on outcome of part one).
Each treatment will be radiolabelled to contain a maximum total dose of 10 MBq 99mTc-DTPA per treatment at time of dosing. Each treatment will consist of up to 5 tablets each radiolabelled with 2MBq per tablet.
Each treatment will contain 50mg Sodium Diatrizoate radiopaque contrast and proprietary Xerient technology designed to release in and coat the duodenum.
The primary purpose of this part of the study is to understand the disintegration behaviour of the formulations in a fasted state.
Part two will comprise of further scintigraphic studies on formulation based on the outcome of part one.
In this study we will use scintigraphic imaging to visualise the gastric emptying of each treatment and confirm the site of release in the gastrointestinal tract. We will also use this technique to determine how quickly the treatment breaks up in the body.
X-ray imaging will also be performed in order to provide information on radiographic appearances of the tablet.Summary of Results
Safety
No serious adverse events (SAEs) were reported in this study. Of the nine subjects treated, four experienced a total of five adverse events (AEs) which were all mild in intensity. Three AEs were classed as treatment emergent (TEAEs), none of which were considered related to the study treatment. No AEs resulted in discontinuation. The TEAEs reported are not unexpected for a group of healthy volunteers. No clinically significant changes in vital signs, ECG or physical examination were observed.Scintigraphic
For all treatments the site of onset of tablet disintegration was observed to be in the stomach or the small intestine. Tablet disintegration in the stomach occurred less frequently in the single tablet treatment (Treatment A) than in the multiple tablet treatments (Treatments B and C). Radiolabel release onset times for all three treatments ranged from 5.0 – 267.5 min post dose.REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0005
Date of REC Opinion
2 Mar 2023
REC opinion
Further Information Favourable Opinion