A Study of Prasugrel in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Prasugrel ODT1 - Tablet; Drug: Prasugrel ODT2 - Tablet; Drug: Prasugrel ODT2 - Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01648790

14686

H7T-EW-TAEQ (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 5 patient groups

5 mg Prasugrel (ODT1)

Experimental group

Description:

5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state.

Treatment:

Drug: Prasugrel ODT1 - Tablet

5 mg Prasugrel (ODT2)

Experimental group

Description:

5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state.

Treatment:

Drug: Prasugrel ODT2 - Tablet

5 mg Prasugrel (ODT2)-Suspension

Experimental group

Description:

5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.

Treatment:

Drug: Prasugrel ODT2 - Suspension

5 mg Prasugrel (ODT2)-Fed

Experimental group

Description:

5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast.

Treatment:

Drug: Prasugrel ODT2 - Tablet

2 mg Prasugrel (ODT2)

Experimental group

Description:

2 mg Prasugrel as ODT2 formulation administered once in the fasted state.

Treatment:

Drug: Prasugrel ODT2 - Tablet