Vorapaxar in the Human Endotoxemia Model

• Status: Completed
• Trial end date: 2016-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet inhibition may also exert positive results on coagulation activation and may beneficially influence the inflammatory response. Since vorapaxar is the first available substance of a new class of platelet inhibitors its effects on the human coagulation system and the inflammatory response will be assessed in the well-established human endotoxemia model.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Vorapaxar

Criteria

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• Intake of any drugs that may interfere with the trial's endpoints or drugs (i.e. platelet inhibitors, anticoagulants, CYP3A4 inhibitors, NSAIDs, selective serotonin reuptake inhibitors, selective noradrenaline and serotonin reuptake inhibitors)

• 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

• Pregnancy or breastfeeding