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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01354496 | A Study of LY2409021 Formulations and the Effect of Food | PHASE1 | COMPLETED | 35 | — | — | Apr 1, 2011 | Oct 1, 2011 | Mar 11, 2019 | 1 | Singapore |
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...