A Study of Prasugrel in Healthy Participants

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01648790
First received: July 20, 2012
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Prasugrel ODT1 - Tablet
Drug: Prasugrel ODT2 - Tablet
Drug: Prasugrel ODT2 - Suspension
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation [ Time Frame: Predose through 8 Hours Post Dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Predose through 8 Hours Post Dose ] [ Designated as safety issue: No ]
    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:
  • Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State [ Time Frame: Predose through 8 Hours Post Dose ] [ Designated as safety issue: No ]
    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 [ Time Frame: Predose through 8 Hours Post Dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 mg Prasugrel (ODT1)
5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state.
Drug: Prasugrel ODT1 - Tablet
Administered orally as tablet.
Other Names:
  • LY640315
  • Effient
  • Efient
Experimental: 5 mg Prasugrel (ODT2)
5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state.
Drug: Prasugrel ODT2 - Tablet
Administered orally as tablet.
Other Names:
  • LY640315
  • Effient
  • Efient
Experimental: 5 mg Prasugrel (ODT2)-Suspension
5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.
Drug: Prasugrel ODT2 - Suspension
Administered orally as suspension.
Other Names:
  • LY640315
  • Effient
  • Efient
Experimental: 5 mg Prasugrel (ODT2)-Fed
5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast.
Drug: Prasugrel ODT2 - Tablet
Administered orally as tablet.
Other Names:
  • LY640315
  • Effient
  • Efient
Experimental: 2 mg Prasugrel (ODT2)
2 mg Prasugrel as ODT2 formulation administered once in the fasted state.
Drug: Prasugrel ODT2 - Tablet
Administered orally as tablet.
Other Names:
  • LY640315
  • Effient
  • Efient

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648790

Locations
United States, Texas
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
Sponsors and Collaborators
Eli Lilly and Company
Daiichi Sankyo Inc.
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01648790     History of Changes
Other Study ID Numbers: 14686, H7T-EW-TAEQ
Study First Received: July 20, 2012
Results First Received: August 30, 2013
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prasugrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014