Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP1815 A · 1 trial · 2 indications
The time to onset of disintegration/release for each EDP1815 formulation will be measured by using the time 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
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| EDP1815 capsule A | DRUG | 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 | DRUG | 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 | DRUG | 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 |
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 com...