An Assessment of Prasugrel on Healthy Adults and Sickle Cell Adults

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01178099
First received: August 6, 2010
Last updated: January 12, 2012
Last verified: January 2012
Results First Received: January 12, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Anemia, Sickle Cell
Intervention: Drug: Prasugrel

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Prasugrel Healthy Participants Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
Prasugrel Sickle Cell Disease Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).

Participant Flow:   Overall Study
    Prasugrel Healthy Participants     Prasugrel Sickle Cell Disease  
STARTED     13     13  
COMPLETED     13     12  
NOT COMPLETED     0     1  
Physician Decision                 0                 1  



  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
Prasugrel 10 mg SD; 5 mg MD (Healthy) Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
Prasugrel 10 mg SD; 7.5 mg MD (Healthy) Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease) Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (MD).
Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease) Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
Total Total of all reporting groups

Baseline Measures
    Prasugrel 10 mg SD; 5 mg MD (Healthy)     Prasugrel 10 mg SD; 7.5 mg MD (Healthy)     Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease)     Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease)     Total  
Number of Participants  
[units: participants]
  4     9     4     9     26  
Age  
[units: years]
Mean ± Standard Deviation
  24.8  ± 3.0     27.6  ± 6.5     28.0  ± 14.8     29.6  ± 6.8     27.9  ± 7.6  
Gender  
[units: participants]
         
Female     4     2     3     2     11  
Male     0     7     1     7     15  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     1     1     0     0     2  
Not Hispanic or Latino     3     8     4     9     24  
Unknown or Not Reported     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     1     0     0     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     2     1     4     9     16  
White     1     8     0     0     9  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United Kingdom     4     9     4     9     26  



  Outcome Measures
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1.  Primary:   Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel’s Active Metabolite, R-138727   [ Time Frame: Time of dosing up to 8 hours post-dose on Day 1 and Day 12 ]

2.  Primary:   Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727   [ Time Frame: Day 1, Day 12 ]

3.  Secondary:   Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12   [ Time Frame: Baseline, Day 12 ]

4.  Secondary:   Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel’s Inactive Metabolites, R-95913, R-106583, and R-119251   [ Time Frame: Day 1, Day 12 ]

5.  Secondary:   Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12   [ Time Frame: Baseline, Day 12 ]

6.  Secondary:   Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12   [ Time Frame: Day 12 ]

7.  Secondary:   Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12   [ Time Frame: Baseline, Day 12 ]

8.  Secondary:   Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12   [ Time Frame: Baseline, Day 12 ]

9.  Secondary:   Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12   [ Time Frame: Day 12 ]

10.  Secondary:   Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251   [ Time Frame: Day 1, Day 12 ]

11.  Secondary:   Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12   [ Time Frame: Baseline, Day 12 ]

12.  Secondary:   Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12   [ Time Frame: Baseline, Day 12 ]

13.  Secondary:   Change From Baseline in the Area Under the Aggregation Curve at Day 12   [ Time Frame: Baseline, Day 12 ]

14.  Secondary:   Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12   [ Time Frame: Baseline, Day 12 ]

15.  Secondary:   P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12   [ Time Frame: Day 12 ]


  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
No text entered.  


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: NCT01178099     History of Changes
Other Study ID Numbers: 13746, H7T-MC-TAEJ
Study First Received: August 6, 2010
Results First Received: January 12, 2012
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service