Vorapaxar in the human endotoxemia model - LPS_Vorapaxar

Medical University of Vienna0 个研究点开始时间: 2016年5月10日最近更新: 2017年4月3日

适应症

试验速览

暂无简介。

•=18 years of age
•=60 kg bodyweight
•Normal findings in medical history and physical examination unless the investigator considers the abnormality to be clinically irrelevant
•Normal laboratory values unless the investigator considers abnormalities to be clinically irrelevant
•Willingness to comply with the trial’s safety demands (to refrain from excessive sporting activities two weeks after Vorapaxar intake, i.e. full contact sports, climbing, mountain biking etc.)
•Ability to understand the purpose and nature of the study, as well as the associated risks
•No planned surgeries or other medical interventions in the planned study period
•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 16
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Intake of any drugs that may interfere with the trial’s endpoints or drugs (i.e. platelet inhibitors, anticoagulants, CYP3A4 inhibitors, NSAIDs, SSRI, SNRI)
•Positive results of HIV or hepatitis virology
•Acute illness with systemic inflammatory reactions
•Known allergies, hypersensitivities or intolerances to any of the used substances
•Acute or recent bleeding episodes, increased risk of bleeding at the discretion of the investigator
•History of stroke, transient ischemic attacks or intracerebral hemorrhage
•Known coagulation or platelet disorders
•Participation in an LPS trial within 6 weeks of the first study day
•Severe liver or kidney dysfunction

发起方