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Study of Prasugrel in Korean Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01591317
Recruitment Status : Completed
First Posted : May 4, 2012
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteers
Intervention Drug: Prasugrel
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prasugrel - 60 mg/10 mg Prasugrel - 30 mg/7.5 mg Prasugrel - 30 mg/5 mg
Hide Arm/Group Description Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
Period Title: Overall Study
Started 10 10 10
Completed 10 10 10
Not Completed 0 0 0
Arm/Group Title Prasugrel - 60 mg/10 mg Prasugrel - 30 mg/7.5 mg Prasugrel - 30 mg/5 mg Total
Hide Arm/Group Description Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 30 participants
28.2  (5.3) 25.9  (5.2) 26.0  (4.1) 26.7  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 30 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
10
 100.0%
10
 100.0%
30
 100.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Asian Number Analyzed 10 participants 10 participants 10 participants 30 participants
10 10 10 30
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 10 participants 10 participants 10 participants 30 participants
10 10 10 30
1.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose
Hide Description AUC from time zero to the last quantifiable plasma concentration (tlast)
Time Frame Day 1 predose up to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Prasugrel 60 mg loading dose given once orally
Prasugrel 30 mg loading dose given once orally
Overall Number of Participants Analyzed 10 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram times hour/milliliter (ng*h/mL)
600
(16%)
283
(17%)
2.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose
Hide Description [Not Specified]
Time Frame Day 1 predose up to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Prasugrel 60 mg loading dose given once orally
Prasugrel 30 mg loading dose given once orally
Overall Number of Participants Analyzed 10 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram/milliliter (ng/mL)
498
(41%)
271
(39%)
3.Primary Outcome
Title Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose
Hide Description [Not Specified]
Time Frame Day 1 predose up to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Prasugrel 60 mg Prasugrel 30 mg
Hide Arm/Group Description:
Prasugrel 60 mg loading dose given once orally
Prasugrel 30 mg loading dose given once orally
Overall Number of Participants Analyzed 10 20
Median (Full Range)
Unit of Measure: hours
0.50
(0.25 to 1.00)
0.50
(0.25 to 1.00)
4.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Hide Description AUC from time zero to the last quantifiable plasma concentration (tlast)
Time Frame Day 11 predose to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Prasugrel 10 mg Prasugrel 7.5 mg Prasugrel 5 mg
Hide Arm/Group Description:
Prasugrel 10 mg once a day orally for 10 days
Prasugrel 7.5 mg once a day orally for 10 days
Prasugrel 5 mg once a day orally for 10 days
Overall Number of Participants Analyzed 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
78.1
(24%)
58.4
(21%)
38.3
(24%)
5.Primary Outcome
Title Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Hide Description [Not Specified]
Time Frame Day 11 predose to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Prasugrel 10 mg Prasugrel 7.5 mg Prasugrel 5 mg
Hide Arm/Group Description:
Prasugrel 10 mg once a day orally for 10 days
Prasugrel 7.5 mg once a day orally for 10 days
Prasugrel 5 mg once a day orally for 10 days
Overall Number of Participants Analyzed 10 10 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
92.3
(36%)
61.9
(37%)
41.0
(73%)
6.Primary Outcome
Title Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Hide Description [Not Specified]
Time Frame Day 11 predose to 24 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Prasugrel 10 mg Prasugrel 7.5 mg Prasugrel 5 mg
Hide Arm/Group Description:
Prasugrel 10 mg once a day orally for 10 days
Prasugrel 7.5 mg once a day orally for 10 days
Prasugrel 5 mg once a day orally for 10 days
Overall Number of Participants Analyzed 10 10 10
Median (Full Range)
Unit of Measure: hours
0.50
(0.25 to 0.50)
0.50
(0.25 to 0.52)
0.38
(0.25 to 1.00)
7.Secondary Outcome
Title Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
Hide Description ADP-induced PRU represents the rate and extent of ADP-stimulated platelet aggregation and serves as a biomarker of clinical efficacy, with lower values indicating greater P2Y12 platelet inhibition
Time Frame Predose up to 24 hours post dose on Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Prasugrel - 60 mg/10 mg Prasugrel - 30 mg/7.5 mg Prasugrel - 30 mg/5 mg
Hide Arm/Group Description:
Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: PRU
Day 1, predose 290  (36.2) 273  (39.6) 297  (48.9)
Day 1, 0.5 hours 118  (120) 107  (95.5) 172  (102)
Day 1, 1 hour 13.5  (18.9) 19.0  (42.6) 46.0  (45.0)
Day1, 2 hours 3.30  (2.16) 7.00  (11.3) 20.1  (29.0)
Day 1, 4 hours 2.70  (1.89) 3.10  (1.73) 12.1  (24.0)
Day 1, 24 hours 7.10  (9.52) 5.10  (2.56) 26.9  (32.2)
Day 10, predose 34.8  (51.4) 35.1  (25.0) 121  (53.7)
Day 11, predose 39.6  (61.9) 26.4  (27.7) 123  (45.8)
Day 11, 24 hours 24.4  (26.7) 27.2  (31.8) 107  (53.7)
8.Secondary Outcome
Title Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
Hide Description PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges
Time Frame Predose up to 24 hours post dose on Day 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Prasugrel - 60 mg/10 mg Prasugrel - 30 mg/7.5 mg Prasugrel - 30 mg/5 mg
Hide Arm/Group Description:
Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
Overall Number of Participants Analyzed 10 10 10
Mean (Standard Deviation)
Unit of Measure: Percent inhibition of PRU
Day 1, predose 9.90  (10.9) 6.80  (5.57) 9.90  (11.4)
Day 1, 0.5 hours 64.9  (35.5) 66.9  (28.9) 48.8  (29.2)
Day 1, 1 hour 95.8  (6.00) 94.2  (13.9) 86.9  (12.3)
Day1, 2 hours 98.9  (0.568) 97.7  (3.47) 94.0  (8.26)
Day 1, 4 hours 99.2  (0.632) 99.1  (0.738) 96.8  (6.00)
Day 1, 24 hours 97.8  (2.94) 98.3  (0.675) 92.0  (9.51)
Day 10, predose 89.3  (15.7) 87.6  (8.82) 63.6  (14.7)
Day 11, predose 88.5  (18.4) 91.2  (9.07) 64.8  (12.9)
Day 11, 24 hours 92.5  (7.43) 91.0  (10.0) 67.0  (17.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prasugrel - 60 mg/10 mg Prasugrel - 30 mg/7.5 mg Prasugrel - 30 mg/5 mg
Hide Arm/Group Description Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
All-Cause Mortality
Prasugrel - 60 mg/10 mg Prasugrel - 30 mg/7.5 mg Prasugrel - 30 mg/5 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Prasugrel - 60 mg/10 mg Prasugrel - 30 mg/7.5 mg Prasugrel - 30 mg/5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Prasugrel - 60 mg/10 mg Prasugrel - 30 mg/7.5 mg Prasugrel - 30 mg/5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      4/10 (40.00%)      3/10 (30.00%)    
General disorders       
Chest discomfort  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Vessel puncture site paraesthesia  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion  1  1/10 (10.00%)  1 1/10 (10.00%)  1 2/10 (20.00%)  2
Nervous system disorders       
Dizziness  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Epistaxis  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Rhinorrhoea  1  0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Sputum retention  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Vascular disorders       
Hot flush  1  1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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: NCT01591317    
Other Study ID Numbers: 11990
H7T-FW-TACQ ( Other Identifier: Eli Lilly and Company )
First Submitted: May 2, 2012
First Posted: May 4, 2012
Results First Submitted: September 4, 2012
Results First Posted: October 4, 2012
Last Update Posted: October 4, 2012