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 purpose of this study is to find out how safe BAY3389934 is when given together with aspirin and to see how the two affect blood clotting in healthy participants.
To do this, the researchers will assess the number and severity of medical problems in healthy adult participants after receiving BAY3389934 alone and in combination with aspirin and compare them with the medical problems when participants received either drug alone.
These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they are related to study treatments.
All participants will receive a single dose of aspirin tablet prior to the study. Researchers will check their response to decide whether they can participate in the study. Eligible participants will then receive the following three treatments, each at different time and in a different order assigned randomly.
Treatment A:
* no treatment the day prior to receiving study treatment. * BAY3389934 as an infusion into a vein on Day 1.
Treatment B:
* a single high-dose aspirin tablet on the day prior to receiving study treatment. * a single-low dose aspirin tablet on Day 1.
Treatment C:
* a single high-dose aspirin tablet on the day prior to receiving study treatment. * a single low-dose aspirin tablet followed by BAY3389934 4 hours continuous infusion into a vein on Day 1.
There will be a gap of 3 days after Treatment A, and 14 days after Treatments B and C, when participants will not be given any treatment.
Each participant will be in the study for around 2 months with up to 6 visits to the study clinic. They will visit the study clinic:
* twice, before the treatment starts * once, during each of the three treatment periods * once, at the end of the treatment
During the study, the doctors and their study team will
* check participants' health by performing tests such as blood and urine tests, measuring blood pressure, heart rate and checking heart health using an electrocardiogram (ECG). * ask the participants questions about how they are feeling and any adverse events they are having.
In this study, the participants will not benefit from taking of BAY3389934. However, the study will provide information on how BAY3389934 may be helpful in people with blood clotting problems caused due to sepsis.
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/m² (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.
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.
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Treatment groupsSee each treatment group below.