In Vitro Interaction Between Ticagrelor and Its Active Metabolite and Their Effects on Salicylic Acid

NCT ID: NCT01777516

Last Updated: 2013-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-01-31

Brief Summary

This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic acid. The study consist of two parts of in-vitro study as follows;

• Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite.
• Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite and their effect on the pharmacodynamics of salicylic acid on platelet aggregation tests with the agonist of arachidonic acid.

Detailed Description

This is a in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite (AR-C124910XX) and their effects on the pharmacodynamics of salicylic acid. The study consist of two parts of in-vitro study as follows;

• Part 1 : in-vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite. Platelet aggregation tests with the agonist of adenosine diphosphate(ADP) will be assessed on the in-vitro mixtures of blank plasma and randomized paired concentrations of ticagrelor + AR-C124910XX.
• Part 2 : in vitro study to evaluate the pharmacodynamic interaction between ticagrelor and its active metabolite. Platelet aggregation tests with the agonist of arachidonic acid will be assessed on the in-vitro mixtures of blank plasma plus randomized paired concentrations of ticagrelor and AR-C124910XX and the invitro mixtures with blank plasma and ticagrelor + AR-C124910XX + salicylic acid.

Conditions

Cardiovascular Diseases

Study Groups

healthy volunteers

1 group with no treatment : They provide the blank plasma to be used at in vitro study.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects with body weight more than 50 kg and within 20% of the ideal body weight: ideal body weight = (height[cm] - 100)*0.9.
• Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria

• Subjects who have a history or presence of any clinically significant diseases.
• Subjects who have any congenital or acquired haematological diseases.
• Subjects who had whole blood donation within the last 2 months and component blood donation within the last month.
• Subject who took any concomitant medication including non-steroidal antiinflammatory drugs(NASIDs) and vitamins currently or within 7 days prior to blood sampling.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea National Enterprise for Clinical Trials

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Hyeong-Seok Lim

Associate Professor of the Department of Pharmacology and Therapeutics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyeong-Seok Lim, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

A070001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AsanMC_CPT_PAT_2012

Identifier Type: -

Identifier Source: org_study_id