PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ticagrelor/prasugrel

• Registration Number: NCT01876797
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-13
• Study Start: 2013-07
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ticagrelor-prasugrel	ticagrelor/prasugrel	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximal Platelet Aggregation(MPA)	0,15 min,0.5 min, 1h,2h,4h,8h and 24h	platelet aggregation will be tested using light transmission aggregometry

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of