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.
Verified date | March 2023 |
Source | Evelo Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | BDD Pharma Ltd | Glasgow | Scotland |
Lead Sponsor | Collaborator |
---|---|
Evelo Biosciences, Inc. |
United Kingdom,
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 |
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