PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

Asan Medical Center

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ticagrelor/prasugrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01876797

Hyeong-Seok Lim

Details and patient eligibility

About

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.

1. Blood Sampling Times

   1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose
   2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose

2. Bioanalysis

   1. plasma Ticagrelor
   2. plasma AR-C124910XX (active metabolite of ticagrelor)
   3. plasma R-95913 (inactive metabolite of prasugrel)
   4. plasma R-13727 (active metabolite of prasugrel)

3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)

4. PK-PD Modeling analysis

Enrollment: 12 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. male aged 19 - 45 years at screening visit
2. body weight at least 60 kg at screening visit
3. body mass index 18 - 30 kg/m2
4. SBP 90 - 149 mmHg and DBP 60 - 99 mmHg and pulse rate(beat per minute) 45 - 100 at screening visit

Exclusion criteria

1. any history of or having any clinically significant abnormalities
2. any gastrointestinal disorder having impact on absorption of study drug
3. any history of hypersensitivity of ticagrelor or prasugrel or compounds related study drugs
4. 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
5. any history of taking other study drug within 60 days before dosing
6. 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
7. any history of taking metabolic inducer or inhibitor
8. overuse (caffeine: > 5 units/day , alcohol: > 21 units /week, smoking: > 10 cigarettes/day)
9. positive serology testy(Hbs antigen, HIV, Hepatitis C virus, Syphilis)
10. any abnormality in clinical laboratory tests result or any ECG finding considered to be inadequate by investigator

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 1 patient group

ticagrelor-prasugrel

Other group

Description:

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.

Treatment:

Drug: ticagrelor/prasugrel