Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms

NCT05066373 | Completed Phase 1

• 1 other identifier: EDP1815-104
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Disintegration; Healthy

Outcome Measures

Primary Outcomes (2)

• Time to onset of radiolabel release

  The time to onset of disintegration/release for each EDP1815 formulation will be measured by using the time of onset of radiolabel release

  up to 12 hours

• Site of onset of radiolabel release

  The site of onset of disintegration/release for each EDP1815 formulation will be determined by using the site of onset of radiolabel release

  up to 12 hours

Secondary Outcomes (5)

• Gastric emptying time

  up to 12 hours

• Small intestinal transit time

  up to 12 hours

• Colon arrival time

  up to 12 hours

• Time to 50% release (T50)

  up to 12 hours

• Time to 90% release (T90)

  up to 12 hours

Study Arms (3)

EDP1815 capsule A (fasted)

EXPERIMENTAL

In part 1, 12 healthy volunteers will receive a single dose of EDP1815 capsule A, dosed in the fasted state

Drug: EDP1815 capsule A

EDP1815 capsule B (fasted/fed)

EXPERIMENTAL

In part 1, 2 \& 3, 12 healthy volunteers will receive a single dose of EDP1815 capsule B, dosed in the fasted and/or fed state

Drug: EDP1815 capsule B

EDP1815 tablet (fasted/fed)

EXPERIMENTAL

In part 1, 3 \& 4, 12 healthy volunteers will receive a single dose of EDP1815 tablet, dosed in the fasted and/or fed state

Drug: EDP1815 tablet

Interventions

EDP1815 capsule A DRUG

EDP1815 capsule A is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The capsule is radio-labeled with approximately 4 MBq 99mTc-DTPA

EDP1815 capsule A (fasted)

EDP1815 capsule B DRUG

EDP1815 capsule B is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The capsule is radio-labeled with approximately 4 MBq 99mTc-DTPA

EDP1815 capsule B (fasted/fed)

EDP1815 tablet DRUG

EDP1815 tablet is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The tablet is radio-labeled with approximately 4 MBq 99mTc-DTPA

EDP1815 tablet (fasted/fed)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Body weight ≥50 kg and BMI 18-30 kg/m²
• Healthy

You may not qualify if:

• History or presence of any medical condition or abnormal laboratory test findings at screening that could affect the study conduct/results, or make the participant unlikely to fully complete the study or potentially adversely affect their safety due to taking part.
• History of non-self-limiting gastrointestinal disorders, or currently suffering from disease known to impact gastric emptying, e.g. migraine, Type 1 or Type 2 diabetes mellitus.
• Any contraindication to gamma scintigraphy.
• Any non-removable metal objects such as metal plates, screws in the chest or abdominal area.
• Total radiation dosimetry value which contraindicates participation.
• Use of prescribed medication within 14 days prior to first dose which could interfere with the study procedures or affect gastric emptying and/or gut transit.
• Use of over-the-counter (OTC) medication, including vitamins, pro and prebiotics and natural or herbal remedies, within 48 hours prior to first dose.
• History of alcohol or other substance abuse.
• Current smoker or recently discontinued smoking (less than 3 months).
• History of allergy to any component of the dosage form or any other allergy which contraindicates participation.
• Vegetarian or vegan.
• Participation in this or another clinical study with an investigational drug within the prior 12 weeks, or more than four other clinical studies in the prior 12 month period.
• Participants unwilling to comply with contraception requirements from first dose until 90 days (use of condom/spermicide in addition to use of protocol-specified highly effective contraception by female partners who could become pregnant)

Sponsors & Collaborators

• Evelo Biosciences, Inc.: lead

Study Sites (1)

BDD Pharma Ltd

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Howard Stevens, BPharm PhD

  BDD Pharma Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: August 9, 2021
• Primary Completion: August 11, 2022
• Study Completion: August 26, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)