New clotting drug and aspirin: safe together? early study seeks answers
NCT ID NCT07652723
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times
Summary
This early-stage study tests whether a new drug (BAY3389934) for blood clotting problems in sepsis can be safely given with aspirin. Sixteen healthy adults will receive the drug alone, aspirin alone, and both together in random order. The goal is to check for side effects and see how the two drugs affect blood clotting. Participants will not benefit directly, but results will guide future use in sepsis patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinical Pharmacology of Miami, LLC - Cardiology Department
RECRUITINGMiami, Florida, 33014, United States
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