A study to learn about the amount of asundexian in the blood and the effect of food on its levels when healthy participants take it as adult or pediatric formulation

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bayer AG

Participant type

Healthy volunteers

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

6 May 2026 → ongoing

Decision date (initial)

2026-03-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

To investigate the pharmacokinetics of asundexian after a single oral dose of 50 mg pediatric formulation compared to the 50 mg tablet in the fasted state and to investigate the effect of a high-fat, high-calorie meal on the pharmacokinetics of the 50 mg asundexian pediatric formulation relative to fasted state

Secondary objectives 1

1. To investigate safety and tolerability of a single dose of 50 mg asundexian as pediatric formulation and tablet in the fasted state, and 50 mg pediatric formulation in fed state

Conditions and MedDRA coding

Prevention of thromboembolic events

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-003144-PIP01-21

Plan to share IPD

No

IPD plan description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.​

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, ECG, and vital signs
3. BMI within the range 18 to 29.9 kg/m2 (both inclusive) at the screening.
4. Male or female participants
5. 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 14

1. 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.
2. 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.
3. 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.
4. Febrile illness within 4 weeks before the start of the first study intervention.
5. Known coagulation disorders (e.g., von Willebrand’s disease, hemophilia).
6. Known disorders with increased bleeding risk (e.g., periodontosis, symptomatic hemorrhoids, acute gastritis, peptic ulcer etc.).
7. Known sensitivity to common causes of bleeding (e.g., nasal etc.), heavy menstrual periods in female participants.
8. Known or suspected liver disorders (e.g. Morbus Gilbert/ Meulengracht) and bile secretion/flow (cholestasis, also history of it).
9. 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.
10. Intake of specified food or beverages containing grapefruit, pomelo, tangelo, Seville oranges within 2 weeks before first study intervention administration.
11. Intake of quinine containing beverages like tonic water etc. within 2 weeks before first study intervention administration.
12. 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
13. Systolic blood pressure below 90 mmHg or above 140 mmHg at screening and upon confirmation of eligibility
14. Diastolic blood pressure below 60 mmHg or above 90 mmHg at screening and upon confirmation of eligibility

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. 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

Secondary endpoints 2

1. 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
2. Number of participants who experienced serious and non-serious TEAEs after administration of 50 mg asundexian as pediatric formulation in the fed state

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bayer AG

Sponsor organisation

Bayer AG

Address

-

City

Leverkusen

Postcode

51368

Country

Germany

Scientific contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Public contact point

Organisation

Bayer AG

Contact name

Therapeutic Area Head

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications