Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy volunteers. It is currently in Phase 1 clinical development, with the primary purpose of evaluating the drug in healthy participants. The specific therapeutic indication has not been established, as it is still in early-stage research.
Prasugrel ODT1 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug in healthy volunteers.
Prasugrel ODT1 is in Phase 1 clinical development. This early-stage trial is designed to assess the drug's safety, tolerability, and pharmacokinetic profile in healthy participants. The study has been completed, and the drug remains investigational, meaning it has not yet been approved for any medical use.
Prasugrel ODT1 has one completed clinical trial registered under NCT01648790, titled 'A Study of Prasugrel in Healthy Participants.' This Phase 1 study enrolled 20 healthy volunteers in the United States, with participants aged 18 years and older. The trial was controlled but not double-blinded.
Prasugrel ODT1 is a formulation of prasugrel, a small molecule drug. The 'ODT1' designation likely refers to an orally disintegrating tablet formulation, though this is not explicitly stated. The clinical trial NCT01648790 evaluates prasugrel in healthy participants, indicating it is the same active pharmaceutical ingredient.