Clinical trial NCT01777516: In Vitro Interaction Between Ticagrelor and Its Active Metabolite and Their Effects on Salicylic Acid
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Platelet Aggregation
Cardiovascular Diseases
Salicylic Acid
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korea National Enterprise for Clinical Trials
First posted: 2013-01-29
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers

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.

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.

Primary outcomes:
measure: Platelet aggregation(%) of the in vitro mixtures of blank plasma and drugs of the randomized paired concentrations
timeFrame: The tolerability of volunteers after blood sampling will be followed for the duration of hospital stay, an expected average of 5 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Hyeong-Seok Lim, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: