Scintigraphic evaluation of EDP1815 oral dosage forms

• Research type

  Research Study

• Full title

  A Phase 1, single centre, open label, crossover study in healthy volunteers using scintigraphy to evaluate the gastrointestinal behaviour of EDP1815 oral dosage forms.

• IRAS ID

  299851

• Contact name

  Lyn Smith

• Contact email

  Lyn.Smith@bddpharma.com

• Sponsor organisation

  Evelo Bioscience Inc

• Eudract number

  2021-003054-22

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  This study is designed to assess the in vivo release and gastrointestinal behaviour of tablets and capsules containing EDP1815. EDP1815 is a pharmaceutical preparation of a single strain of Prevotella histicola bacteria, currently in Phase 2 clinical development for the treatment of psoriasis (a skin condition which is thought to be caused by a problem with the immune system) and COVID-19. It is available as enteric coated capsules or tablets.

  The following concentrations are being dosed throughout this study:
  A’capsule: containing 8.0xe10 total Prevotella histocola cells/ dosage unit
  A2 capsule and tablet: containing 3.2xe11 total Prevotella histocola cells / dosage unit
  A2 capsule: containing 1.6xe11 total Prevotella histocola cells/ dosage unit
  A2 tablet: containing 2.3xe11 total Prevotella histocola cells/ dosage unit

  This study consist of multiple parts (12 subjects in each part):

  Part One, two and three of the study is now complete and comprised of scintigraphic studies on various concentrations of A' and A2 tablets and capsules with different levels of enteric coat in both the fed and fasted conditions.
  
  Part Four will involve a fourth cohort of subjects and will comprise further scintigraphic studies on the A2 tablets containing 2.3xe11 total Prevotella histocola cells/ dosage unit with different levels of polymer coating. Subjects may be dosed in the fed or fasted states. Subjects in Part 4 will attend a maximum of 4 assessment visits.

  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. To look at these parameters we will add a small amount of radioactive material to the tablet or capsule.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  21/LO/0450

• Date of REC Opinion

  20 Jul 2021

• REC opinion

  Further Information Favourable Opinion