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

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT01777516
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study Start: 2012-12
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-24
• Last Update Submitted: 2013-01-24
• Study First Posted: 2013-01-29
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet aggregation(%) of the in vitro mixtures of blank plasma and drugs of the randomized paired concentrations	The tolerability of volunteers after blood sampling will be followed for the duration of hospital stay, an expected average of 5 hours.	Plasma which were collected from healthy volunteers were used to make mixtures of drugs, ticagrelor, AR-C124910XX and salicylic acid. ADP and arachidonic acid were used as the agonists of platelet aggregation.

Trial Locations

Locations (1)

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