Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04958135 | Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants | PHASE1 | COMPLETED | 18 | — | — | May 30, 2021 | Aug 4, 2021 | Mar 6, 2026 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Sequence 1: Acoramidis | EXPERIMENTAL | Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fasted conditions. Period 2: Acoramidis as an immediate-release tablet under fed conditions. There will be a washout period of at least 14 days between acoramidis dosing. |
| Sequence 2: Acoramidis | EXPERIMENTAL | Participants will receive acoramidis once each period as a single dose under fasted or fed conditions as follows: Period 1: Acoramidis as an immediate-release tablet under fed conditions. Period 2: Acoramidis as an immediate-release tablet under fasted conditions. There will be a washout period of at least 14 days between acoramidis dosing. |
| Name | Type | Description |
|---|---|---|
| Acoramidis | DRUG | Film-coated immediate release oral tablet. |
Key Inclusion Criteria: * Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation (hematology, chemist...