Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Prasugrel in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01648790
Recruitment Status : Completed
First Posted : July 24, 2012
Results First Posted : November 5, 2013
Last Update Posted : November 5, 2013
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 20, 2012
First Posted Date  ICMJE July 24, 2012
Results First Submitted Date  ICMJE August 30, 2013
Results First Posted Date  ICMJE November 5, 2013
Last Update Posted Date November 5, 2013
Study Start Date  ICMJE July 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2013)
  • Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
  • Pharmacokinetics: Maximum concentration (Cmax) of LY640315 test and reference formulation [ Time Frame: Baseline through 8 days after administration of study drug ]
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY640315 reference and test formulation [ Time Frame: Baseline through 8 days after administration of study drug ]
Change History Complete list of historical versions of study NCT01648790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2013)
  • Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2012)
  • Pharmacokinetics: Maximum concentration (Cmax) of LY640315 test formulation in fasted and fed state [ Time Frame: Baseline through 8 days after administration of study drug ]
  • Pharmacokinetics: Area under the concentration curve (AUC) of LY640315 test formulation in fasted and fed state [ Time Frame: Baseline through 8 days after administration of study drug ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Prasugrel in Healthy Participants
Official Title  ICMJE Relative Bioavailability of Prasugrel Orally Disintegrating Tablet Formulations and the Effect of Food on the Bioavailability of the Orally Disintegrating Tablet in Healthy Subjects
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Prasugrel ODT1 - Tablet
    Administered orally as tablet.
    Other Names:
    • LY640315
    • Effient
    • Efient
  • Drug: Prasugrel ODT2 - Tablet
    Administered orally as tablet.
    Other Names:
    • LY640315
    • Effient
    • Efient
  • Drug: Prasugrel ODT2 - Suspension
    Administered orally as suspension.
    Other Names:
    • LY640315
    • Effient
    • Efient
Study Arms  ICMJE
  • Experimental: 5 mg Prasugrel (ODT1)
    5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered once in the fasted state.
    Intervention: Drug: Prasugrel ODT1 - Tablet
  • Experimental: 5 mg Prasugrel (ODT2)
    5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered once in the fasted state.
    Intervention: Drug: Prasugrel ODT2 - Tablet
  • Experimental: 5 mg Prasugrel (ODT2)-Suspension
    5 mg Prasugrel as ODT2 formulation dispersed in water administered once, in the fasted state.
    Intervention: Drug: Prasugrel ODT2 - Suspension
  • Experimental: 5 mg Prasugrel (ODT2)-Fed
    5 mg Prasugrel as ODT2 formulation administered once, following a standardized breakfast.
    Intervention: Drug: Prasugrel ODT2 - Tablet
  • Experimental: 2 mg Prasugrel (ODT2)
    2 mg Prasugrel as ODT2 formulation administered once in the fasted state.
    Intervention: Drug: Prasugrel ODT2 - Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01648790
Other Study ID Numbers  ICMJE 14686
H7T-EW-TAEQ ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Daiichi Sankyo, Inc.
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP