Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY3389934 · 2 trials · 3 indications
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.
| Arm | Type | Description |
|---|---|---|
| Treatment sequence A-B-C | EXPERIMENTAL | 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 sequence A-C-B | EXPERIMENTAL | 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 sequence B-A-C | EXPERIMENTAL | 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 sequence B-C-A | EXPERIMENTAL | 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 sequence C-A-B | EXPERIMENTAL | 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 sequence C-B-A | EXPERIMENTAL | 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. |
| Cohort 1 of BAY3389934 | EXPERIMENTAL | Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours. |
| Cohort 2 of BAY3389934 | EXPERIMENTAL | Subjects will receive titrated dose of BAY3389934 as continuous infusion over up to 96 hours. |
| Name | Type | Description |
|---|---|---|
| Aspirin | DRUG | Single oral dose of 500 mg tablet or 100 mg tablet. |
| BAY3389934 | DRUG | 4 hours infusion of BAY3389934 in Dose A. |
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. ...
BAY 3389934 is an investigational small molecule being developed for sepsis, sepsis associated disseminated intravascular coagulation (DIC), and drug-drug interaction studies. It is being studied in patients with sepsis induced coagulopathy and in healthy volunteers to assess its safety, dosing, and effects on blood clotting.
BAY 3389934 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The drug is currently in Phase 1 clinical development for hematology indications.
BAY 3389934 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 1 trials are ongoing or completed to evaluate its safety, tolerability, and pharmacological effects in healthy volunteers and patients with sepsis induced coagulopathy.
BAY 3389934 is being studied in several Phase 1 trials. NCT06854640 is recruiting patients with sepsis induced coagulopathy in Belgium, France, Germany, and the Netherlands. NCT07176728 was completed in healthy Japanese volunteers. NCT07652723 is recruiting healthy participants in the United States to study drug-drug interactions with aspirin.
Yes, BAY 3389934 and BAY3389934 refer to the same investigational drug. The compound is being developed by Bayer AG under these interchangeable names. Clinical trial NCT07652723 uses the name BAY3389934, while other trials use BAY 3389934.