Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2409021 Reference Form · 1 trial · 1 indication
AUC from time 0 to infinity (AUC0-∞).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 - LY2409021 reference form | EXPERIMENTAL | A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state |
| Cohort 1 - LY2409021 medium test form fed | EXPERIMENTAL | Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal |
| Cohort 1 - LY2409021 medium test form fasted | EXPERIMENTAL | Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state |
| Cohort 2 - LY2409021 low test form fasted | EXPERIMENTAL | Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state |
| Cohort 2 - LY2409021 medium test form fasted | EXPERIMENTAL | Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state |
| Cohort 2 - LY2409021 high test form fasted | EXPERIMENTAL | Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state |
| Name | Type | Description |
|---|---|---|
| LY2409021 Reference Form | DRUG | Administered orally |
| LY2409021 Test-Med Formulation (medium particle size) | DRUG | Administered orally |
| LY2409021 Test-High Formulation (high particle size) | DRUG | Administered orally |
| LY2409021 Test-Low Formulation (low particle size) | DRUG | Administered orally |
Inclusion Criteria: * Must be healthy male or a healthy female who cannot become pregnant * Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive * Blood pressure as well as blood and urine laboratory test results must be acceptable for the study * The veins m...
LY2409021 is an investigational small molecule being studied in healthy volunteers. It is not approved for any disease and remains in clinical development. The only completed trial evaluated its formulations and the effect of food in healthy participants.
LY2409021 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company sponsored a Phase 1 study of the drug in healthy volunteers.
LY2409021 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no trials are currently active.
LY2409021 has one completed clinical trial, NCT01354496, titled "A Study of LY2409021 Formulations and the Effect of Food." This Phase 1 study enrolled 35 healthy volunteers in Singapore and was a controlled, randomized trial.
LY2409021 is not FDA approved. It is an investigational small molecule that has only been studied in a Phase 1 clinical trial involving healthy volunteers. The drug remains in clinical development and has not been authorized for any medical use.