How safe BAY3389934 is when given alone or with aspirin in healthy adults
Official title: Open-label Randomized, Three-fold Cross-over, Single-center Interaction Study to Investigate the Influence of Multiple Doses of Acetylsalicylic Acid (ASA) (Aspirin) on the Pharmacodynamics of BAY 3389934 in Healthy Participants.
Run by Bayer · NCT07652723 · Data updated 2026-11-12
This study tests BAY3389934, alone and with aspirin, to see if it’s safe and how it affects blood clotting in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | May 29, 2026 |
| Main results expected | March 10, 2027 |
| Study ends | March 10, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT07652723 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–55 who meet screening health criteria and agree to contraception/birth control requirements.
✕Probably not a fit
Participants who do not have a medical need for anticoagulant therapy or who do not tolerate or respond to the study drugs.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 study in healthy volunteers to assess the safety and blood-clotting effects of BAY3389934 when given by itself and together with aspirin. The trial measures how the drug behaves in the body and its impact on clotting tests, to understand potential interactions with aspirin. Participants are healthy adults aged 18 to 55, and the study includes careful monitoring of vital signs, labs, and heart function. The goal is to determine if the combination is safe before exploring its use in patients with sepsis-related clotting problems.
Why it matters
Potential benefit: If successful, the study could support safer use of BAY3389934 alone or with aspirin, guiding future research in patients with sepsis-related clotting.
How similar studies have gone: Previous early studies in similar anticoagulant approaches have shown selective safety signals; this trial adds data on a new agent and its interaction with aspirin.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.).
Where it's running
-
Clinical Pharmacology of Miami, LLC - Cardiology Department
Miami, Florida, United States Recruiting
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: 0018888422937
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Long-acting HIV PrEP and contraception PK study in AGYW
This study tests how long-acting cabotegravir for PrEP interacts with hormonal contraception in young women.
-
How genetic variations affect drug interactions with efavirenz, methadone, and tizanidine
This study is testing how different genetic variations affect how well the drugs efavirenz, methadone, and tizanidine work together in healthy volunteers.
-
Long-acting injectable treatment for HIV in young women
This study is testing a long-acting injectable treatment for HIV in young women to see if it works better than standard pills and helps improve their health and prevent unintended pregnancies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.