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

• Status: Recruiting
• Trial end date: 2022-02-15
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Evelo Biosciences, Inc.

Criteria

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 another clinical study with an investigational drug within the prior 12 weeks, or more than three 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)