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A Study of Prasugrel in Healthy Participants

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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Prasugrel ODT1 - Tablet
Drug: Prasugrel ODT2 - Tablet
Drug: Prasugrel ODT2 - Suspension
Enrollment 20
Recruitment Details  
Pre-assignment Details Participants were to be given 5 single doses of prasugrel in 5 different sequences on each of 5 consecutive mornings of treatment.
Arm/Group Title Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5
Hide Arm/Group Description Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast
Period Title: Treatment 1
Started 4 4 4 4 4
Received at Least 1 Dose of Study Drug 4 4 4 4 4
Completed 4 4 4 4 4
Not Completed 0 0 0 0 0
Period Title: Treatment 2
Started 4 4 4 4 4
Completed 4 4 4 4 4
Not Completed 0 0 0 0 0
Period Title: Treatment 3
Started 4 4 4 4 [1] 4
Completed 4 4 4 3 4
Not Completed 0 0 0 1 0
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0
[1]
Withdrew consent prior to dosing on this treatment day.
Period Title: Treatment 4
Started 4 4 4 3 4
Completed 4 4 4 3 4
Not Completed 0 0 0 0 0
Period Title: Treatment 5
Started 4 4 4 3 4
Completed 4 4 4 3 4
Not Completed 0 0 0 0 0
Arm/Group Title All Participants
Hide Arm/Group Description 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® formulation (ODT1) or orally disintegrating tablet containing Magnasweet® formulation (ODT2) given either on top of tongue or dispersed in water administered in either the fasted or fed state. 2 mg prasugrel ODT2 given on top of tongue in the fasted state.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
39.3  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
2
  10.0%
Male
18
  90.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
5
  25.0%
Not Hispanic or Latino
15
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
1
   5.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  55.0%
White
8
  40.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test and Reference Formulation
Hide Description 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.
Time Frame Predose through 8 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
Arm/Group Title 5 mg Prasugrel (ODT1) 5 mg Prasugrel (ODT2)
Hide Arm/Group Description:
5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
Overall Number of Participants Analyzed 19 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
28.6
(41%)
28.1
(51%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 mg Prasugrel (ODT1), 5 mg Prasugrel (ODT2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric Least Squares Means
Estimated Value 0.983
Confidence Interval (2-Sided) 90%
0.819 to 1.18
Estimation Comments Least Squares (LS) means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.
2.Primary Outcome
Title Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Reference and Test Formulation
Hide Description 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.
Time Frame Predose through 8 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
Arm/Group Title 5 mg Prasugrel (ODT1) 5 mg Prasugrel (ODT2)
Hide Arm/Group Description:
5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
Overall Number of Participants Analyzed 19 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour per milliliter (ng*h/mL)
27.1
(31%)
26.8
(38%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 mg Prasugrel (ODT1), 5 mg Prasugrel (ODT2)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric Least Squares Means
Estimated Value 0.987
Confidence Interval (2-Sided) 90%
0.918 to 1.06
Estimation Comments LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.
3.Secondary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of Prasugrel Test Formulation in Fasted and Fed State
Hide Description 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.
Time Frame Predose through 8 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
Arm/Group Title 5 mg Prasugrel (ODT1) 5 mg Prasugrel (ODT2) 5 mg Prasugrel (ODT2)-Suspension 5 mg Prasugrel (ODT2)-Fed 2 mg Prasugrel (ODT2)
Hide Arm/Group Description:
5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
Overall Number of Participants Analyzed 19 19 20 20 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
28.6
(41%)
28.1
(51%)
31.5
(45%)
7.79
(60%)
8.81
(47%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 mg Prasugrel (ODT2), 5 mg Prasugrel (ODT2)-Fed
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric Least Squares Means
Estimated Value 0.280
Confidence Interval (2-Sided) 90%
0.233 to 0.335
Estimation Comments LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.
4.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Curve (AUC) of Prasugrel Test Formulation in Fasted and Fed State
Hide Description 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.
Time Frame Predose through 8 Hours Post Dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic population consists of all participants who received at least one dose of study drug and have evaluable pharmacokinetic data.
Arm/Group Title 5 mg Prasugrel (ODT1) 5 mg Prasugrel (ODT2) 5 mg Prasugrel (ODT2)-Suspension 5 mg Prasugrel (ODT2)-Fed 2 mg Prasugrel (ODT2)
Hide Arm/Group Description:
5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
Overall Number of Participants Analyzed 19 19 20 20 19
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour per milliliter (ng*h/mL)
27.1
(31%)
26.8
(38%)
27
(32%)
20.8
(39%)
8.97
(31%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 5 mg Prasugrel (ODT2), 5 mg Prasugrel (ODT2)-Fed
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric Least Squares Means
Estimated Value 0.779
Confidence Interval (2-Sided) 90%
0.724 to 0.837
Estimation Comments LS means were determined by mixed-effect linear models with treatment, period, sequence as fixed effects, and participants nested within sequence as random effect.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5 mg Prasugrel (ODT1) 5 mg Prasugrel (ODT2) 5 mg Prasugrel (ODT2)-Suspension 5 mg Prasugrel (ODT2)-Fed 2 mg Prasugrel (ODT2)
Hide Arm/Group Description 5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state. 5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state. 5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state. 5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast. 2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
All-Cause Mortality
5 mg Prasugrel (ODT1) 5 mg Prasugrel (ODT2) 5 mg Prasugrel (ODT2)-Suspension 5 mg Prasugrel (ODT2)-Fed 2 mg Prasugrel (ODT2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
5 mg Prasugrel (ODT1) 5 mg Prasugrel (ODT2) 5 mg Prasugrel (ODT2)-Suspension 5 mg Prasugrel (ODT2)-Fed 2 mg Prasugrel (ODT2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/19 (0.00%)      0/20 (0.00%)      0/20 (0.00%)      0/19 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5 mg Prasugrel (ODT1) 5 mg Prasugrel (ODT2) 5 mg Prasugrel (ODT2)-Suspension 5 mg Prasugrel (ODT2)-Fed 2 mg Prasugrel (ODT2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/19 (5.26%)      0/19 (0.00%)      0/20 (0.00%)      2/20 (10.00%)      1/19 (5.26%)    
Gastrointestinal disorders           
Gingival bleeding  1  0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Injury, poisoning and procedural complications           
Procedural dizziness  1  0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders           
Myalgia  1  0/19 (0.00%)  0 0/19 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1 0/19 (0.00%)  0
Nervous system disorders           
Syncope  1  1/19 (5.26%)  1 0/19 (0.00%)  0 0/20 (0.00%)  0 0/20 (0.00%)  0 0/19 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01648790     History of Changes
Other Study ID Numbers: 14686
H7T-EW-TAEQ ( Other Identifier: Eli Lilly and Company )
First Submitted: July 20, 2012
First Posted: July 24, 2012
Results First Submitted: August 30, 2013
Results First Posted: November 5, 2013
Last Update Posted: November 5, 2013