PKPD Study of Ticagrelor and Prasugrel in Healthy Korean... | NCT01876797

Studies
PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males

NCT01876797

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Mar 3, 2014Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

ticagrelor/prasugrel

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

Jun 10, 2013

First Submission Date that Met QC Criteria

Jun 11, 2013

First Posted Date

Jun 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2014

Last Update Posted Date

Mar 3, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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
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)
Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)
PK-PD Modeling analysis

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ticagrelor/prasugrel	Drug		ticagrelor-prasugrel	ticagrelor :2 tablets of Brilinta® 90 mg prasugrel : 6 tablets of Effient® 10 mg

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Measure	Description	Time Frame
adverse event monitoring	all adverse event will be collected	up to 1 week

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Hyeong-Seok Lim, Professor	Asan Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul	Seoul	138-736	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25697420	Derived	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.

ID	Term
D000077486	Ticagrelor
D000068799	Prasugrel Hydrochloride

ID	Term
D000241	Adenosine
D011684	Purine Nucleosides
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring