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

March 23, 2023 updated by: Evelo Biosciences, Inc.

A Phase 1, Single Centre, Open Label, Crossover Study in Healthy Volunteers Using Scintigraphy to Evaluate the Gastrointestinal Behaviour of EDP1815 Oral Dosage Forms.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase I single centre, 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.

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 of EDP1815 capsules over up to 4 treatment periods.

The data generated in Part 2 will be assessed prior to progressing to Part 3 to select formulations and doses to be studied. Part 3 will include gamma scintigraphy in up to 12 healthy volunteers receiving single doses of EDP1815 capsules or tablets over up to 4 treatment periods.

The data generated in Part 3 will be assessed prior to progressing to Part 4 to select formulations and doses to be studied. Part 4 will include gamma scintigraphy in up to 12 healthy volunteers receiving single doses of EDP1815 tablets over up to 4 treatment periods.

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. The drug will be given fasted or fed.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G4 0SF
        • BDD Pharma Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Key Inclusion Criteria:

  1. Male
  2. Body weight ≥50 kg and BMI 18-30 kg/m²
  3. Healthy

Key Exclusion Criteria:

  1. 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.
  2. 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.
  3. Any contraindication to gamma scintigraphy.
  4. Any non-removable metal objects such as metal plates, screws in the chest or abdominal area.
  5. Total radiation dosimetry value which contraindicates participation.
  6. 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.
  7. Use of over-the-counter (OTC) medication, including vitamins, pro and prebiotics and natural or herbal remedies, within 48 hours prior to first dose.
  8. History of alcohol or other substance abuse.
  9. Current smoker or recently discontinued smoking (less than 3 months).
  10. History of allergy to any component of the dosage form or any other allergy which contraindicates participation.
  11. Vegetarian or vegan.
  12. 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.
  13. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EDP1815 capsule A (fasted)
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 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
Experimental: EDP1815 capsule B (fasted/fed)
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 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
Experimental: EDP1815 tablet (fasted/fed)
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to onset of radiolabel release
Time Frame: up to 12 hours
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
Time Frame: up to 12 hours
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastric emptying time
Time Frame: up to 12 hours
Gastrointestinal transit parameters will be measured using the gastric emptying time
up to 12 hours
Small intestinal transit time
Time Frame: up to 12 hours
Gastrointestinal transit parameters will be measured using the small intestinal transit time
up to 12 hours
Colon arrival time
Time Frame: up to 12 hours
Gastrointestinal transit parameters will be measured using the colon arrival time
up to 12 hours
Time to 50% release (T50)
Time Frame: up to 12 hours
The radiolabel release kinetics of each EDP1815 formulation will be measured using the time to 50% release (T50)
up to 12 hours
Time to 90% release (T90)
Time Frame: up to 12 hours
The radiolabel release kinetics of each EDP1815 formulation will be measured using the time to 90% release (T90)
up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Evelo Biosciences, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Howard Stevens, BPharm PhD, BDD Pharma Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EDP1815-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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