Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acoramidis · 1 trial · 1 indication
| 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...
Acoramidis is an investigational small molecule being studied in healthy adult participants. It is not approved for any disease and is currently in Phase 1 clinical development. The only completed trial assessed the effect of food on a single dose of the drug.
Acoramidis is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.
Acoramidis is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in healthy participants to assess how food affects a single dose.
Acoramidis has one completed Phase 1 trial, NCT04958135, titled 'Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants.' The trial enrolled 18 participants in the United States and was a controlled, randomized study.
Acoramidis is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, but it has not been approved for any medical use.