BAY3389934 + Aspirin for Drug Interaction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety of a new drug, BAY3389934, when combined with aspirin. Researchers are studying BAY3389934 for its potential to address blood clotting issues related to sepsis, a serious condition that can cause organ damage. Since both BAY3389934 and aspirin influence blood clotting, researchers want to observe their interaction and any possible side effects. The trial seeks healthy adults who can take aspirin without issues. Participants will receive both treatments in varying sequences, with their health closely monitored throughout the study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In earlier studies, researchers found BAY3389934 to be generally safe, meaning most participants did not experience serious side effects. For instance, in a study with healthy volunteers, BAY3389934 was tested at various doses to assess safety and side effects. The results indicated that the drug was safe enough for further research.
Aspirin is a well-known medicine used to prevent blood clots. Although both BAY3389934 and aspirin affect blood clotting, they operate differently. Researchers aim to determine if using them together is safe and how they interact. So far, evidence suggests that BAY3389934 is well-tolerated in humans, especially when used alone. However, ongoing studies will provide more information about its safety when combined with aspirin.12345Why are researchers excited about this trial's treatments?
Researchers are excited about BAY3389934 because it offers a novel approach to drug interactions by examining its effects in combination with aspirin. Unlike standard treatments that simply aim to alleviate symptoms, BAY3389934 is administered via a 4-hour infusion, which can allow for precise control over dosage and timing, potentially enhancing its effectiveness and safety profile. This investigational treatment could provide deeper insights into how medications interact in the body, paving the way for more informed and individualized treatment plans in the future.
What evidence suggests that this trial's treatments could be effective for blood clotting problems due to sepsis?
Research shows that BAY3389934 blocks two important proteins, Factor IIa (thrombin) and Factor Xa, which help blood clot. By blocking these proteins, BAY3389934 may reduce or stop excessive clotting, a problem in sepsis. Aspirin prevents blood cells called platelets from sticking together and is often used to lower heart-related risks. This trial will explore the effects of BAY3389934 and aspirin administered in different sequences. Studies suggest that using BAY3389934 and aspirin together might offer a two-part approach to managing blood clotting by affecting different parts of the clotting process. While more research is needed, early findings suggest this combination could be promising for people with clotting issues related to sepsis.678910
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18-55 with a BMI between 18.0 and 29.9, who are not pregnant or at risk of pregnancy, and willing to use contraception if needed. People cannot join if they have bleeding disorders, liver problems, recent surgery, severe allergies (including to aspirin), or any condition that increases bleeding risk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three different treatments in a randomized sequence, with BAY3389934 and aspirin administered in various combinations.
Wash-out
Participants undergo a wash-out period between treatments to clear the drugs from their system.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events.
What Are the Treatments Tested in This Trial?
Interventions
- Aspirin
- BAY3389934
Trial Overview
The study tests the safety of BAY3389934 alone and together with aspirin in healthy people. Participants receive different combinations of these drugs in separate sessions to see how they affect blood clotting and whether using them together causes more side effects.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1. Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence. Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1. Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence. Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1. Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence. Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1. Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence. Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1. Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence. Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
Treatment A: no treatment on day -1, 4 hours infusion of BAY3389934 on day 1 in Dose A. Treatment B: 500 mg aspirin on day -1, 100 mg aspirin on day 1. Treatment C: 500 mg aspirin on day -1, 100 mg aspirin on day 1 followed by 4 hours infusion of BAY3389934 in Dose A. Participants will receive the treatments in mentioned sequence. Study periods will be separated by a wash-out phase of at least 3 days after Treatment A and at least 14 days after Treatments B, C, respectively.
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Who Is Running the Clinical Trial?
Bayer
Lead Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Citations
A Study to Learn About How Safe BAY3389934 is and ...
By blocking them, BAY3389934 may slow down or stop excessive clotting. Aspirin is a drug that prevents platelets from clumping together.
Drug-drug interaction | Study 22366
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 ...
NCT07652723 | A Study to Learn About How Safe ...
BAY3389934 may slow down or stop excessive clotting. BAY3389934 may be helpful in people with blood clotting problems caused due to sepsis.
Clinical Outcomes of Aspirin Interaction with Other Non- ...
Aspirin reduces cardiovascular (CV) risk attributed to the use of NANSAIDs. Aspirin appears to maintain its cardioprotective effect en, ibuprofen, meloxicam ...
5.
theglobeandmail.com
theglobeandmail.com/investing/markets/markets-news/Tipranks/4226008/bayer-tests-new-sepsis-clotting-drug-with-aspirin-early-trial-signals-for-bayry-investors/Bayer Tests New Sepsis Clotting Drug With Aspirin
BAY3389934 is an IV drug in development to slow excess clotting seen in severe infections, while standard oral aspirin is used here at high and ...
BAY 3389934
In June 2026, Tango disclosed preliminary PDAC combination data with daraxonrasib, including a 92% ORR and generally tolerable safety profile.
NCT06854640 | A Study to Learn About How Safe BAY ...
... safety and the tolerability of the drug. If no serious side effects are reported from the first group, the second group will receive higher dose of BAY3389934.
BAY-3389934 - Drug Targets, Indications, Patents
A first in human single dose escalation study to investigate the safety, tolerability, pharmacokinetics, and pharmcodynamics of BAY 3389934 compared with ...
A Potent and Selective Small-Molecule Dual Factor IIa/Xa ...
BAY 3389934 hydrochloride (31) is currently being investigated in clinical phase 1, aiming at a new standard of care in acute coagulation ...
Sepsis || Coagulopathy | Study 22265
A study to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy.
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