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

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ClinicalTrials.gov Identifier: NCT01777516
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : January 29, 2013
Sponsor:
Collaborator:
Korea National Enterprise for Clinical Trials
Information provided by (Responsible Party):
Hyeong-Seok Lim, 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.

Condition or disease
Cardiovascular Diseases

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
Actual Enrollment : 24 participants
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 Start Date : December 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
Plasma and white blood cells


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy volunteers
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777516


Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Korea National Enterprise for Clinical Trials
Investigators
Principal Investigator: Hyeong-Seok Lim, M.D., PhD Asan Medical Center

Responsible Party: Hyeong-Seok Lim, Associate Professor of the Department of Pharmacology and Therapeutics, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01777516     History of Changes
Other Study ID Numbers: AsanMC_CPT_PAT_2012
A070001 ( Other Grant/Funding Number: Korea National Enterprise For Clinical Trials )
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

Keywords provided by Hyeong-Seok Lim, Asan Medical Center:
Platelet Aggregation
Cardiovascular Diseases
Salicylic Acid

Additional relevant MeSH terms:
Cardiovascular Diseases
Ticagrelor
Salicylic Acid
Salicylates
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors