A Relative Bioavailability Study of a Prasugrel Orally Disintegrating Tablet

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01430091
First received: September 6, 2011
Last updated: October 5, 2012
Last verified: October 2012
Results First Received: October 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sickle Cell Disease
Interventions: Drug: Prasugrel (clinical formulation)
Drug: Prasugrel (Orally Disintegrating Tablet [ODT])

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Participants Received 5 milligrams (mg) prasugrel as either the clinical tablet or as an orally disintegrating tablet (ODT).

Participant Flow:   Overall Study
    Participants  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Participants Total Number of Study Participants

Baseline Measures
    Participants  
Number of Participants  
[units: participants]
  18  
Age  
[units: years]
Mean ± Standard Deviation
  37.1  ± 13.7  
Gender  
[units: participants]
 
Female     2  
Male     16  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     18  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     2  
Black or African American     0  
White     11  
More than one race     4  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to the Last Measureable Concentration (AUC[0-tlast]) of Prasugrel’s Active Metabolite (PRAS-AM)   [ Time Frame: Pre-dose up to 8 hours post-dose after each treatment ]

2.  Primary:   Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel’s Active Metabolite (PRAS-AM)   [ Time Frame: Pre-dose up to 8 hours post-dose after each treatment ]

3.  Primary:   Pharmacokinetics: Time of Maximum Concentration (Tmax) of Prasugrel’s Active Metabolite (PRAS-AM)   [ Time Frame: Pre-dose up to 8 hours post-dose after each treatment ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01430091     History of Changes
Other Study ID Numbers: 13040, H7T-EW-TADQ
Study First Received: September 6, 2011
Results First Received: October 5, 2012
Last Updated: October 5, 2012
Health Authority: United States: Food and Drug Administration