DisintegrationPhase 1NCT05066373
Scintigraphy Study to Evaluate the Gastrointestinal Behavior of EDP1815 Oral Dosage Forms
A Phase 1 study testing EDP1815 capsule A, EDP1815 capsule B and EDP1815 tablet in people with Disintegration and Healthy, run by Evelo Biosciences, Inc. at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Disintegration, Healthy
- What is being tested?
- EDP1815 capsule A, EDP1815 capsule B and EDP1815 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Aug 2021to 26 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Body weight ≥50 kg and BMI 18-30 kg/m²
- Healthy
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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).
Read the 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.
- Conditions
- Disintegration, Healthy
- Being tested
- EDP1815 capsule A, EDP1815 capsule B, EDP1815 tablet
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDP1815 capsule ADrug
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 BDrug
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 tabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: EDP1815 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 12 hours
Secondary outcomes (5)
Gastric emptying time
Gastrointestinal transit parameters will be measured using the gastric emptying time
Measured: up to 12 hours
Small intestinal transit time
Gastrointestinal transit parameters will be measured using the small intestinal transit time
Measured: up to 12 hours
Colon arrival time
Gastrointestinal transit parameters will be measured using the colon arrival time
Measured: up to 12 hours
Time to 50% release (T50)
The radiolabel release kinetics of each EDP1815 formulation will be measured using the time to 50% release (T50)
Measured: up to 12 hours
Time to 90% release (T90)
The radiolabel release kinetics of each EDP1815 formulation will be measured using the time to 90% release (T90)
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start9 Aug 2021
- Primary completion11 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisintegrationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelo Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Stevens, BPharm PhD, Principal investigator, BDD Pharma Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066373
- Sponsor's protocol ID
- EDP1815-104
- Status last verified
- Mar 2023
- First submitted
- 23 Sep 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT05066373
- Acronym / sponsor ID
- EDP1815-104
- Conditions
- Disintegration, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Evelo Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EDP1815 capsule A (fasted) | Experimental | Drug: EDP1815 capsule AIn part 1, 12 healthy volunteers will receive a single dose of EDP1815 capsule A, dosed in the fasted state |
| EDP1815 capsule B (fasted/fed) | Experimental | Drug: EDP1815 capsule BIn part 1, 2 \& 3, 12 healthy volunteers will receive a single dose of EDP1815 capsule B, dosed in the fasted and/or fed state |
| EDP1815 tablet (fasted/fed) | Experimental | Drug: EDP1815 tabletIn part 1, 3 \& 4, 12 healthy volunteers will receive a single dose of EDP1815 tablet, dosed in the fasted and/or fed state |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Body weight ≥50 kg and BMI 18-30 kg/m²
- Healthy
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDP1815 capsule AEDP1815 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 A (fasted) |
| EDP1815 capsule BEDP1815 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 capsule B (fasted/fed) |
| EDP1815 tabletEDP1815 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 | Drug | EDP1815 tablet (fasted/fed) |
Primary outcome
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
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
5 secondary outcomes
Gastric emptying time
Time frame: up to 12 hours
Small intestinal transit time
Time frame: up to 12 hours
Colon arrival time
Time frame: up to 12 hours
Time to 50% release (T50)
Time frame: up to 12 hours
Time to 90% release (T90)
Time frame: up to 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Stevens, BPharm PhD principal investigator
BDD Pharma Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EDP1815 capsule A, EDP1815 capsule B and EDP1815 tablet in people with Disintegration and Healthy, run by Evelo Biosciences, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to onset of radiolabel release (time frame: up to 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.