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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01313286 | A Study to Compare Two Forms of LY2608204 in Healthy People | PHASE1 | COMPLETED | 16 | — | — | Mar 1, 2011 | Apr 1, 2011 | Oct 5, 2018 | 1 | Singapore |
Area under the concentration versus time curve from zero to infinity \[AUC(0-∞)\] was calculated from the data. The values for AUC were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
Maximum observed drug concentration (Cmax) was observed from the data. The values for Cmax were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
| Arm | Type | Description |
|---|---|---|
| LY2608204 Reference, LY2608204 Test | EXPERIMENTAL | Single oral 80 mg dose of LY2608204 reference formulation in period 1; single oral 80 mg dose of LY2608204 test formulation in period 2. There is a washout period of at least 14 days between dosing periods. |
| LY2608204 Test, LY2608204 Reference | EXPERIMENTAL | Single oral 80 mg dose of LY2608204 test formulation in period 1; single oral 80 mg dose of LY2608204 reference formulation in period 2. There is a washout period of at least 14 days between dosing periods. |
| Name | Type | Description |
|---|---|---|
| LY2608204 Reference | DRUG | Administered orally |
| LY2608204 Test | DRUG | Administered orally. |
Inclusion Criteria: * Must be a healthy male or a female who cannot become pregnant * Must have body mass index (BMI) of 18.5 to 32 kg/m², inclusive * Blood pressure as well as blood and urine laboratory test results must be acceptable for the study * The veins must be suitable for easy blood colle...