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Clinical Trial Summary

This study is to find out how different types of capsules or tablets containing EDP1815 move through the GI tract and release the drug after being swallowed. The capsules and tablets also contain a very small dose of a commonly used radioactive label called technetium-99m which is released in the GI tract to be seen on pictures taken by a scanner (gamma scintigraphy).

Clinical Trial Description

This is a Phase I single centre, open-label, 2-part, crossover, gamma scintigraphy study to investigate the gastrointestinal transit and disintegration kinetics of capsule and tablet formulations of EDP1815 (which contains a specific pure strain of Prevotella histicola, a natural human commensal organism). In Part 1, up to 12 healthy male volunteers will receive single doses of EDP1815 administered either as capsules or tablets in 4 treatment periods separated by up to 21 days. Each capsule or tablet will contain the radio-isotope technetium-99m complexed to DTPA; 99mTc-DTPA, does not enter the systemic circulation and is routinely used for investigations of this type. Imaging via gamma scintigraphy will be used to assess the gut transit time and disintegration location/rate of the capsules/tablets. In three of the periods the drug will be given fasted, and in the final period the effect of food will be assessed. The data generated in Part 1 will be assessed prior to progressing to Part 2 to select formulations and doses to be studied. Part 2 will include gamma scintigraphy in up to 12 healthy volunteers receiving single doses or EDP1815 capsules or tablets over up to 4 treatment periods. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05066373
Study type Interventional
Source Evelo Biosciences, Inc.
Contact Louise Dyce
Phone 0141 552 8791
Email [email protected]
Status Recruiting
Phase Phase 1
Start date August 9, 2021
Completion date February 15, 2022

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