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Also known as Prasugrel ODT1 - Tablet
Prasugrel ODT1 · 1 trial · 1 indication
Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 milligrams (mg) prasugrel dosing. Pharmacokinetics will measure prasugrel's (LY640315) active metabolite.
AUC(0-tlast) = area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) and the reference formulation is defined as the orally disintegrating tablet without Magnasweet® (ODT1) specific to the 5 mg prasugrel dosing. Pharmacokinetics will measure prasugrel's active metabolite.
| Arm | Type | Description |
|---|---|---|
| 5 mg Prasugrel (ODT1) | EXPERIMENTAL | 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state. |
| 5 mg Prasugrel (ODT2) | EXPERIMENTAL | 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state. |
| 5 mg Prasugrel (ODT2)-Suspension | EXPERIMENTAL | 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state. |
| 5 mg Prasugrel (ODT2)-Fed | EXPERIMENTAL | 5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast. |
| 2 mg Prasugrel (ODT2) | EXPERIMENTAL | 2 mg Prasugrel as ODT2 formulation administered once in the fasted state. |
| Name | Type | Description |
|---|---|---|
| Prasugrel ODT1 - Tablet | DRUG | Administered orally as tablet. |
| Prasugrel ODT2 - Tablet | DRUG | Administered orally as tablet. |
| Prasugrel ODT2 - Suspension | DRUG | Administered orally as suspension. |
Inclusion Criteria: * Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m\^2) Exclusion Criteria: * No known allergies to Prasugrel or related compound * No regular alcohol intake greater than 21 units per week for males or 14 units per week for females
Prasugrel ODT1 is an investigational small molecule developed by Eli Lilly and Company. It is an orally disintegrating tablet formulation studied in healthy adult volunteers. The clinical program is at Phase 1, and the specific therapeutic indication has not been disclosed.
Prasugrel ODT1 targets P2RY12, the platelet P2Y12 receptor. It acts as an antagonist at this receptor. Antagonism of P2RY12 is the mechanism studied in the Phase 1 program, which enrolled healthy participants rather than patients with a disclosed disease.
Prasugrel ODT1 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 1 study of the orally disintegrating tablet formulation conducted in the United States.
Prasugrel ODT1 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
Prasugrel ODT1 has been studied in one completed Phase 1 trial, NCT01648790, titled A Study of Prasugrel in Healthy Participants. It enrolled 20 healthy volunteers in the United States, was randomized and controlled, and included participants aged 18 years and older of all sexes.
Yes. Prasugrel ODT1 is also known as Prasugrel ODT1 - Tablet. Both names refer to the same Eli Lilly and Company orally disintegrating tablet formulation that targets P2RY12 and has been evaluated in the completed Phase 1 study NCT01648790.