Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY2608204 Reference · 1 trial · 1 indication
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...
LY2608204 is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus. It has also been evaluated in healthy volunteers to compare different formulations. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
LY2608204 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting early-stage clinical trials to evaluate the safety and tolerability of this investigational compound.
LY2608204 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in patients with Type 2 Diabetes and another in healthy volunteers. The drug remains investigational and has not received regulatory approval for any indication.
LY2608204 has been studied in two completed Phase 1 trials. NCT01247363 enrolled 20 patients with Type 2 Diabetes in the United States and Singapore. NCT01313286 enrolled 16 healthy volunteers in Singapore to compare two forms of the drug. Both trials are completed.
LY2608204 is the code name used by Eli Lilly for this investigational compound. No alternative brand names or other designations have been disclosed in the clinical trial information. The drug is identified solely by its LY2608204 designation in the studies.