PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

Study Overview
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Brief Summary
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This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and prasugrel in healthy Korean male subjects. The study is open label, one sequence, crossover design. In period 1, a single oral dose of 180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a single oral dose of 60 mg prasugrel will be administrated. After dosing each period, blood sampling for PK and PD assessment will be conducted. Blood Sampling Times PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose Bioanalysis plasma Ticagrelor plasma AR-C124910XX (active metabolite of ticagrelor) plasma R-95913 (inactive metabolite of prasugrel) plasma R-13727 (active metabolite of prasugrel) Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA) PK-PD Modeling analysis

Official Title
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A Single Dose, Open-label, One Sequence, 2-period, Crossover Study to Characterize the Pharmacokinetics and Pharmacodynamics of Ticagrelor and Prasugrel in Healthy Male Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ticagrelor/prasugrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male aged 19 - 45 years at screening visit body weight at least 60 kg at screening visit body mass index 18 - 30 kg/m2 SBP 90 - 149 mmHg and DBP 60 - 99 mmHg and pulse rate(beat per minute) 45 - 100 at screening visit Exclusion Criteria: any history of or having any clinically significant abnormalities any gastrointestinal disorder having impact on absorption of study drug any history of hypersensitivity of ticagrelor or prasugrel or compounds related study drugs any history of taking original medicines within 30 days before dosing or history of taking prescribed drug within 14 days before dosing or history of taking OTC drug within 7 days before dosing any history of taking other study drug within 60 days before dosing any history of whole blood transfusion within 60 days before dosing or history of blood elements transfusion or history of heaving been transfused within 30 days before 30 days any history of taking metabolic inducer or inhibitor overuse (caffeine: > 5 units/day , alcohol: > 21 units /week, smoking: > 10 cigarettes/day) positive serology testy(Hbs antigen, HIV, Hepatitis C virus, Syphilis) any abnormality in clinical laboratory tests result or any ECG finding considered to be inadequate by investigator

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ticagrelor-prasugrel<br>in period 1, 180 mg of ticagrelor will be administrated at a single oral dose. in period 2, 60 mg of prasugrel will be administrated at a single oral dose. | Drug: ticagrelor/prasugrel<br> <br> * Other names: prasugrel : 6 tablets of Effient® 10 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma ticagrelor parent,AR-C124910XX,R-95913 and R-13727 | 4 mL of blood will be drawn per each collection | 0,10 min,15 min,25 min,0.5h,1h,1.5h,2h,2.5h,4h,6h,8h,12h and 24h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Platelet Aggregation(MPA) | platelet aggregation will be tested using light transmission aggregometry | 0,15 min,0.5 min, 1h,2h,4h,8h and 24h |