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

Healthy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05066373
• Other study ID #: EDP1815-104
• Status: Completed
• Phase: Phase 1
• Start date: August 9, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: March 2023
• Source: Evelo Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 on pictures taken by a scanner (gamma scintigraphy).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 26, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	BDD Pharma Ltd	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Evelo Biosciences, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Gastric emptying time	Gastrointestinal transit parameters will be measured using the gastric emptying time	up to 12 hours
Secondary	Small intestinal transit time	Gastrointestinal transit parameters will be measured using the small intestinal transit time	up to 12 hours
Secondary	Colon arrival time	Gastrointestinal transit parameters will be measured using the colon arrival time	up to 12 hours
Secondary	Time to 50% release (T50)	The radiolabel release kinetics of each EDP1815 formulation will be measured using the time to 50% release (T50)	up to 12 hours
Secondary	Time to 90% release (T90)	The radiolabel release kinetics of each EDP1815 formulation will be measured using the time to 90% release (T90)	up to 12 hours