Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2409021 · 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 Reference Form is an investigational small molecule developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy volunteers, evaluating different formulations of the drug and the effect of food on its behavior. It is not an approved medicine.
LY2409021 Reference Form is made by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the developer responsible for the clinical program, including the Phase 1 study of the drug's formulations and food effect.
LY2409021 Reference Form is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug remains investigational and has not been approved for any indication.
LY2409021 Reference Form has been studied in one completed Phase 1 trial, NCT01354496, titled A Study of LY2409021 Formulations and the Effect of Food. The trial enrolled 35 healthy volunteers in Singapore and was controlled and randomized, though not double blind.
The Phase 1 trial NCT01354496 evaluated different formulations of LY2409021 Reference Form and the effect of food on the drug in healthy volunteers. It enrolled 35 participants aged 21 and older in Singapore, used a controlled and randomized design, and has been completed.