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

NCT05066373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-03-24

No results posted yet for this study

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

Interventions

DRUG

EDP1815 capsule A

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

DRUG

EDP1815 capsule B

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

DRUG

EDP1815 tablet

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

Sponsors & Collaborators

  • Evelo Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Howard Stevens, BPharm PhD · BDD Pharma Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2022-08-11
Completion
2022-08-26

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066373 on ClinicalTrials.gov