The purpose of this study is to investigate how the body processes prasugrel and how prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of prasugrel will be given. Information on side effects will also be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Tablets orally
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, South Korea
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Loading Dose
AUC from time zero to the last quantifiable plasma concentration (tlast)
Time frame: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Loading Dose
Time frame: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Loading Dose
Time frame: Day 1 predose up to 24 hours post dose
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
AUC from time zero to the last quantifiable plasma concentration (tlast)
Time frame: Day 11 predose to 24 hours post dose
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Time frame: Day 11 predose to 24 hours post dose
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Prasugrel's Active Metabolite R-138727 During Maintenance Dose
Time frame: Day 11 predose to 24 hours post dose
Pharmacodynamics: Adenosine Diphosphate (ADP)-Induced P2Y12 Receptor-mediated Platelet Aggregation
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
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Percent Inhibition of Verify Now (VN)-P2Y12 Reaction Units (PRU)
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