A Study of Prasugrel in Healthy Participants
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT01648790
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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
The reference formulation is an orally disintegrating tablet without Magnasweet® (ODT1) and the test formulation is an orally disintegrating tablet containing Magnasweet® (ODT2).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 5 mg Prasugrel (ODT2)-Fed Prasugrel ODT2 - Tablet 5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast. 2 mg Prasugrel (ODT2) Prasugrel ODT2 - Tablet 2 mg Prasugrel as ODT2 formulation administered once in the fasted state. 5 mg Prasugrel (ODT2) Prasugrel ODT2 - Tablet 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state. 5 mg Prasugrel (ODT1) Prasugrel ODT1 - Tablet 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state. 5 mg Prasugrel (ODT2)-Suspension Prasugrel ODT2 - Suspension 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.
- Primary Outcome Measures
Name Time Method Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation Predose through 8 Hours Post Dose 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.
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation Predose through 8 Hours Post Dose 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.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State Predose through 8 Hours Post Dose 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.
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State Predose through 8 Hours Post Dose 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.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Dallas, Texas, United States