Immune response to endotoxin influenced by anti-platelet medications. MedDRA version: 15.1 Level: PT Classification code 10011968 Term: Decreased immune responsiveness System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Trade Name: Brilique (Ticagrelor)
Product Name: Brilique (Ticagrelor)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ticagrelor
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male subjects, or female subjects not of childbearing potential (either surgically sterile or post menopausal). Age between 18 and 65 years inclusive. Non smokers. Body mass index (BMI) between 18 and 28 kg/m2 inclusive, with a body weight between 60-100 kg. Subjects are to be in good health as determined by a medical history, physical examination, vital signs and clinical laboratory test results including renal and liver function and full blood count. Subjects have given their informed consent before any trial-related activity. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: In the opinion of the investigator, subjects with a history of cancer, diabetes or clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, haematological, dermatological, neurological, psychiatric, or other major disorders. Subjects with a history of significant multiple drug allergies or with a known allergy to the study drugs or a medicine chemically related to the study drugs Subjects who have had a clinically significant illness within 4 weeks of dosing Subjects taking regular medicines including NSAIDs, antibiotics, aspirin or anticoagulant therapy. Any clinically significant abnormal laboratory test results at screening. Subjects who have a supine blood pressure at screening, after resting for 5 minutes, higher than 150/90 mmHg or lower than 105/65 mmHg. Subjects who have a supine heart rate at screening, after resting for 5 minutes, outside the range of 50-100 beats/min. Subjects who have received any prescribed systemic or topical medication within two weeks prior to the start of dosing. Limited use of paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) prior to the initiation of the study will not necessarily require exclusion unless there is an ongoing requirement for these medications. Subjects who have received an investigational medicinal product within the previous four months (new chemical entity) or three months (licensed product) or subjects who have received a vaccine within three months preceding the start of dosing. Subjects who have donated any blood or plasma in the month preceding the start of dosing. Subjects who have a history of alcohol or drug abuse. Subjects with mental incapacity or language barriers which preclude adequate understanding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do the anti-clotting medications, ticagrelor and clopidogrel, also have an effect on the immune response?;Secondary Objective: If ticagrelor and/or clopidogrel do affect immune response, by what mechanism does this occur?;Primary end point(s): Area under the curve of graph of CRP over time.;Timepoint(s) of evaluation of this end point: Over 24 hours following administration of endotoxin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): White blood cell count, levels of cytokines (IL-1ra, IL-6, IL-8, IL-10 and TNF-alpha) markers of leucocyte phenotype and function (leucocyte expressed CCR2, CXCR1, CXCR2, CXCR3, CD11b, CD14, CD16, L-selectin and TLR-4), markers of leucocyte degranulation (neutrophil elastase and myeloperoxidase), markers of platelet activity (P2Y12 receptor reactivity, platelet P-selectin expression, formation of platelet leucocyte aggregates and levels of thrombopoietin) and measurements of coagulation (fibrinogen, D-dimer and prothrombin fragment). | — |
Countries
United Kingdom
Contacts
Public ContactJennifer Boston
Sheffield Teaching Hospitals NHS Foundation Trust
Outcome results
None listed