(21174) Relative bioavailability study to investigate the pharmacokinetics of a single oral dose of asundexian administered as 50 mg pediatric formulation in comparison to 50 mg tablet (adult formulation) in fasted state and to investigate the effect of a high-fat, high-calorie meal on the 50 mg pediatric formulation in healthy adult participants

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523677-41-00

Enrollment

Registered

2026-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of thromboembolic events

Brief summary

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, 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

Detailed description

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

Interventions

DRUGBAY 2433334

DRUGAsundexian Bayer 10mg Granules

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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, 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

Measure	Time frame
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, Number of participants who experienced serious and non-serious TEAEs after administration of 50 mg asundexian as pediatric formulation in the fed state	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 7, 2026