NCT07652723
A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants
Recruiting
PHASE1Ages 18–55InterventionalBasic scienceBayer
~16 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:AspirinBAY3389934
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs)
Measured over From first dose of study intervention until 14 days after last study intervention
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Refrain from donating sperm
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
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.).
What this trial measures
- Number of participants with treatment-emergent adverse events (TEAEs)From first dose of study intervention until 14 days after last study intervention
An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.