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

January 24, 2013 updated by: Hyeong-Seok Lim, Asan Medical Center

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
healthy volunteers
1 group with no treatment : They provide the blank plasma to be used at in vitro study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet aggregation(%) of the in vitro mixtures of blank plasma and drugs of the randomized paired concentrations
Time Frame: 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.
The tolerability of volunteers after blood sampling will be followed for the duration of hospital stay, an expected average of 5 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Korea National Enterprise for Clinical Trials

Investigators

  • Principal Investigator: Hyeong-Seok Lim, M.D., PhD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 24, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AsanMC_CPT_PAT_2012
  • A070001 (Other Grant/Funding Number: Korea National Enterprise For Clinical Trials)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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