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A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants

RecruitingPhase 1Ages 18 Years - 55 YearsAllBayer
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In plain words

What the trial is, and whether it could suit you

The study treatment BAY3389934 is under development for people with blood clotting problems that occur due to sepsis. Sepsis is a serious condition that happens when the body's reaction to an infection causes organ damage. It can eventually lead to tiny blood clots formation throughout the body. BAY3389934 aims to work by blocking two important blood clotting proteins, called Factor IIa (thrombin) and Factor Xa, both of which help in blood clotting. By blocking them, BAY3389934 may slow down or stop excessive clotting. Aspirin is a drug that prevents platelets from clumping together. People with sepsis are often given aspirin for underlying heart-related problems. Since aspirin and BAY3389934 both affect how the blood clots, each in a different way, it is important to check whether using them together is safe and whether they change each other's effects on blood clotting. The main purpos

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and cardiac monitoring. * Body mass index within the range 18.0 to 29.9 kg/m\^2 (inclusive) at screening visit. * Male or female (Women of Non-Childbearing Potential \[WONCBP\]) Contraceptive use by participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Male participants: Participants are eligible to participate if they agree to the following during the study intervention period up to at least 1 day after end of infusion of study intervention to ensure sufficient elimination of BAY3389934 (5 times the elimination half-life of BAY3389934 is approximately 5 hours): * Refrain from donating sperm PLUS, either: * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR * Must agree to use contraception /barrier as detailed below: * Agree to use a male condom with female partner use of an additional highly effective contraceptive method with a failure rate of \< 1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person * Female participants: A female participant is eligible to participate if she is a WONCBP. * A WONCBP must have a negative highly sensitive pregnancy test (serum) within 24 hours before the first dose of study intervention, the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: * Medical disorder, condition or history of such that would impair the participant's ability to take part in or complete this study in the opinion of the investigator. * Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal. * Known hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication. * Known severe allergies, e.g. allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions. * Aspirin hypersensitivity/ allergy. * Febrile illness within 2 weeks before the start of the first study intervention. * Known or suspected liver disorders and bile secretion/flow (cholestasis, also history of it). * History of Morbus Meulengracht (Gilbert´s syndrome) or total bilirubin levels above ULN at screening. * History of known or suspected malignant tumors. * Tendency to develop keloids or major scars after injuries. * Participants experienced surgery (6-months prior to first study intervention), or IM injection (2-week prior to first study intervention). * Known disorders with increased bleeding risk (e.g., periodontosis, symptomatic hemorrhoids, acute gastritis, peptic ulcer, vascular malformations and also history of it). * Known sensitivity to common causes of bleeding or bruises (e.g., nasal). * Known congenital or acquired coagulation disorders (e.g. von Willebrand's disease, hemophilia, platelet dysfunction, etc.).
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What it tests

  • Aspirin
  • BAY3389934
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Where

1 site
Clinical Pharmacology of Miami, LLC - Cardiology Department
Miami, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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