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

This study has been completed.
Sponsor:
Collaborator:
Korea National Enterprise for Clinical Trials
Information provided by (Responsible Party):
Hyeong-Seok Lim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01777516
First received: January 22, 2013
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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
Cardiovascular Diseases

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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


Enrollment: 24
Study Start Date: December 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy volunteers
1 group with no treatment : They provide the blank plasma to be used at in vitro study.

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

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 22, 2013
Last Updated: January 24, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Platelet Aggregation
Cardiovascular Diseases
Salicylic Acid

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

ClinicalTrials.gov processed this record on April 15, 2014