A Study of Prasugrel in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the amount of drug available in the body when given to healthy participants as two different formulations with or without a meal. In addition, this study will evaluate how much of the drug gets into the blood stream and how long the body takes to get rid of it. Information about any side effects that may occur will also be collected. Each participant will receive a total of five different treatments. Each treatment is given by mouth, once a day. The treatment period lasts for five consecutive days.

Detailed Description
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The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).

Official Title
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Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Prasugrel ODT1 - Tablet
* Drug: Prasugrel ODT2 - Tablet
* Drug: Prasugrel ODT2 - Suspension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 mg Prasugrel (ODT1)<br>5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state. | Drug: Prasugrel ODT1 - Tablet<br>* Administered orally as tablet.<br>* Other names: Efient;|
| Experimental: 5 mg Prasugrel (ODT2)<br>5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state. | Drug: Prasugrel ODT2 - Tablet<br>* Administered orally as tablet.<br>* Other names: Efient;|
| Experimental: 5 mg Prasugrel (ODT2)-Suspension<br>5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state. | Drug: Prasugrel ODT2 - Suspension<br>* Administered orally as suspension.<br>* Other names: Efient;|
| Experimental: 5 mg Prasugrel (ODT2)-Fed<br>5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast. | Drug: Prasugrel ODT2 - Tablet<br>* Administered orally as tablet.<br>* Other names: Efient;|
| Experimental: 2 mg Prasugrel (ODT2)<br>2 mg Prasugrel as ODT2 formulation administered once in the fasted state. | Drug: Prasugrel ODT2 - Tablet<br>* Administered orally as tablet.<br>* Other names: Efient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation | 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. | Predose through 8 Hours Post Dose | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation | 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. | Predose through 8 Hours Post Dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State | Cmax= maximum concentration measured from predose through 8 hours postdose. Test formulation is defined as the orally disintegrating tablet containing Magnasweet® (ODT2) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite. | Predose through 8 Hours Post Dose | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State | 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) specific to the 5 mg prasugrel dosing in the fasted and fed state. Pharmacokinetics will measure prasugrel's active metabolite. | Predose through 8 Hours Post Dose |