NCT01876797

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. 1.Blood Sampling Times
  2. 2.PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose
  3. 3.PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose
  4. 4.Bioanalysis
  5. 5.plasma Ticagrelor
  6. 6.plasma AR-C124910XX (active metabolite of ticagrelor)
  7. 7.plasma R-95913 (inactive metabolite of prasugrel)
  8. 8.plasma R-13727 (active metabolite of prasugrel)
  9. 9.Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)
  10. 10.PK-PD Modeling analysis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 3, 2014

Status Verified

February 1, 2014

Enrollment Period

1 month

First QC Date

June 10, 2013

Last Update Submit

February 27, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Maximal Platelet Aggregation(MPA)

    0,15 min,0.5 min, 1h,2h,4h,8h and 24h

Other Outcomes (1)

  • adverse event monitoring

    up to 1 week

Study Arms (1)

ticagrelor-prasugrel

OTHER

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

Interventions

ticagrelor/prasugrelDRUG
Also known as: ticagrelor :2 tablets of Brilinta® 90 mg, prasugrel : 6 tablets of Effient® 10 mg
ticagrelor-prasugrel

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 138-736, South Korea

Location

Related Publications (1)

  • Jeon HS, Kim MJ, Choi HY, Kim YH, Kim EH, Kim AR, Park HJ, Bae KS, Lim HS. Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel in healthy male Korean volunteers. Clin Ther. 2015 Mar 1;37(3):563-73. doi: 10.1016/j.clinthera.2015.01.010. Epub 2015 Feb 16.

    PMID: 25697420DERIVED

MeSH Terms

Interventions

TicagrelorPrasugrel Hydrochloride

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Hyeong-Seok Lim, Professor

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 13, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 3, 2014

Record last verified: 2014-02

Locations

KR(1)