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

Cardiovascular Diseases Clinical Trial

— In_vitro_PAT  

Official title:

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 : Concentration-antiplatelet Effect Relationships

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777516
• Other study ID #: AsanMC_CPT_PAT_2012
• Secondary ID: A070001
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: January 24, 2013
• Start date: December 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korea National Enterprise for Clinical Trials

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet aggregation(%) of the in vitro mixtures of blank plasma and drugs of the randomized paired concentrations	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.	The tolerability of volunteers after blood sampling will be followed for the duration of hospital stay, an expected average of 5 hours.	No