We will study in male healthy volunteers whether ticagrelor modulates the inflammatory response to the administration of lipopolysaccharide (LPS) in humans in vivo.
Conditions
Interventions
Trade Name: Brilique
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Clopidogrel
Pharmaceutical Form:
Sponsors
Radboud university medical center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Age = 18 and = 35 years - Male - Healthy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History, signs or symptoms of cardiovascular disease - History of chronic obstructive pulmonary disease (COPD) or asthma - History of hemorrhagic diathesis - Previous spontaneous vagal collapse - Use of any medication - Smoking - Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block, third degree atrioventricular block or a complex bundle branch block - Hypertension (defined as RR systolic > 160 or RR diastolic > 90) - Hypotension (defined as RR systolic 120 µmol/l) - Liver enzyme abnormalities ((defined as ALAT and/or ASAT > twice upper limit of normality) - Thrombocytopenia (<150*109/ml) or anemia (haemoglobin < 8.0 mmol/L) - Any obvious disease associated with immune deficiency - Febrile illness in the week before the LPS challenge. - Participation in another drug trial or donation of blood 3 months prior to the planned LPS Challenge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether ticagrelor, added to acetylsalicylic acid, modulates the inflammatory response to the administration of lipopolysaccharide (LPS) in humans in vivo. ;Secondary Objective: Not applicable. ;Primary end point(s): area under the curve of the pro-inflammatory cytokine TNF-alpha;Timepoint(s) of evaluation of this end point: We will study in male healthy volunteers whether ticagrelor modulates the inflammatory response to the administration of lipopolysaccharide (LPS) in humans in vivo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): area under the curve of the cytokines IL6, IL-10, IL1ra; peak concentrations of the various cytokines; plasma concentration of HMGP1; platelet-monocyte complex formation and markers of platelet function; plasma concentration of adenosine;Timepoint(s) of evaluation of this end point: Blood will drawn from an arterial line at baseline, before administration of the study drug, immediately before administration of LPS, and then serially thereafter up to 24 hours: t=-2, t=0, t=1, t=2, t=3, t=4, t=6 and t=8 hours | — |
Countries
Netherlands
Contacts
Public ContactN.P. Riksen
Radboud university medical center
Outcome results
None listed