ASUNDEXIAN for Thromboembolism

Inclusion criteria

• {"criterion_text":"- Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent."}
• {"criterion_text":"- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, and vital signs"}
• {"criterion_text":"- BMI within the range 18 to 29.9 kg/m2 (both inclusive) at the screening."}
• {"criterion_text":"- Male or female participants"}
• {"criterion_text":"- Contraceptive use by participant or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies."}

Exclusion criteria

• {"criterion_text":"- Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study intervention(s) will not be normal."}
• {"criterion_text":"- Intake of specified food or beverages containing grapefruit, pomelo, tangelo, Seville oranges within 2 weeks before first study intervention administration."}
• {"criterion_text":"- Intake of quinine containing beverages like tonic water etc. within 2 weeks before first study intervention administration."}
• {"criterion_text":"- Findings in the ECG such as a clinically relevant second- degree AV block (if clinically relevant) or third-degree AV block, prolongation of the QRS complex equal or over 120 msec or of the QTc-interval corrected according to Fridericia’s (QTcF) formula over 450 msec identified in a standard 12-lead ECG at screening and upon confirmation of eligibility"}
• {"criterion_text":"- Systolic blood pressure below 90 mmHg or above 140 mmHg at screening and upon confirmation of eligibility"}
• {"criterion_text":"- Diastolic blood pressure below 60 mmHg or above 90 mmHg at screening and upon confirmation of eligibility"}
• {"criterion_text":"- Known hypersensitivity to or intolerance of 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."}
• {"criterion_text":"- Known severe allergies, e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract – allergic asthma, allergies requiring therapy with corticosteroids, urticaria or significant non-allergic drug reactions."}
• {"criterion_text":"- Febrile illness within 4 weeks before the start of the first study intervention."}
• {"criterion_text":"- Known coagulation disorders (e.g., von Willebrand’s disease, hemophilia)."}
• {"criterion_text":"- Known disorders with increased bleeding risk (e.g., periodontosis, symptomatic hemorrhoids, acute gastritis, peptic ulcer etc.)."}
• {"criterion_text":"- Known sensitivity to common causes of bleeding (e.g., nasal etc.), heavy menstrual periods in female participants."}
• {"criterion_text":"- Known or suspected liver disorders (e.g. Morbus Gilbert/ Meulengracht) and bile secretion/flow (cholestasis, also history of it)."}
• {"criterion_text":"- Regular use of prescription drugs, over-the-counter drugs, supplements (e.g., carnitine products, high dose vitamins, anabolics) or herbal products (e.g., St. John’s wort) with the exception of medication used for contraception or hormonal replacement therapy within 14 days prior to the first administration of study intervention."}

Primary endpoints

• {"endpoint_text":"- Cmax, AUC and AUC(0-tlast) for asundexian after a single oral dose of 50 mg pediatric formulation compared to the 50 mg tablet in the fasted state","definition_or_measurement_approach":"Pharmacokinetic parameters (Cmax, AUC, AUC(0-tlast)) derived from plasma concentration-time profiles after a single oral 50 mg dose; comparison between 50 mg pediatric formulation and 50 mg tablet in the fasted state."}
• {"endpoint_text":"- Cmax, AUC and AUC(0-tlast) for asundexian after a single oral dose of 50 mg pediatric formulation after a high-fat meal relative to the fasted state","definition_or_measurement_approach":"Pharmacokinetic parameters (Cmax, AUC, AUC(0-tlast)) derived from plasma concentration-time profiles for the 50 mg pediatric formulation in fed state compared to fasted state."}

Secondary endpoints

• {"endpoint_text":"- Number of participants who experienced serious and non-serious TEAEs after administration of 50 mg asundexian as pediatric formulation and as table in the fasted state","definition_or_measurement_approach":"Count and classification of treatment-emergent adverse events (serious and non-serious) following administration of 50 mg asundexian (pediatric formulation and tablet) in the fasted state."}
• {"endpoint_text":"- Number of participants who experienced serious and non-serious TEAEs after administration of 50 mg asundexian as pediatric formulation in the fed state","definition_or_measurement_approach":"Count and classification of treatment-emergent adverse events (serious and non-serious) following administration of 50 mg asundexian pediatric formulation in the fed state."}

Germany

Earliest CTIS Part Ii Submission Date

24-02-2026

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

10

Number Of Sites

1

Number Of Participants

18

Primary sponsor

Full Name

Bayer AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"sponsor duties codes: 11","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"sponsor duties codes: 4","organisation_type":"Pharmaceutical company"}